Motor Learning in Dysphagia Rehabilitation

Recruiting

Phase N/A Results N/A

Trial Description

The overall goal is to exploit motor learning principles and adjuvant techniques in a novel way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of three forms of biofeedback on training and determine whether adjuvant therapeutic techniques such as non-invasive neural stimulation and reward augment training outcomes has an effect of dysphagia rehabilitation. Outcomes from this research study may change the paradigm for treating swallowing and other internal functions such as speech and voice disorders.

Detailed Description

The overall goal is to exploit motor learning principles in a novel way to enhance dysphagia rehabilitation in patients with dysphagia due to stroke. Dysphagia is swallowing impairment that can lead to serious illness or death due to ingested material entering the trachea (aspiration). Specifically, this study will determine whether lasting behavioral modifications after swallowing training occur with motor learning principles versus standard care. Motor learning principles emphasize continual kinematic assessment through biofeedback during training. However, continual kinematic assessment is rare in standard dysphagia care because swallowing kinematics require instrumentation such as videofluoroscopy (VF) to be seen. Since VF involves radiation exposure and higher costs, submental electromyography (sEMG) is widely used as biofeedback, although it does not image swallowing kinematics or confirm that a therapeutic movement is being trained. This research study will compare three forms of biofeedback on training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology. VF biofeedback training will provide kinematic information about targeted dysphagia training performance, incorporating motor learning principles. sEMG biofeedback training will provide non-kinematic information about targeted dysphagia training performance and, thus, does not incorporate motor learning principles. A mixed biofeedback training, which involves VF biofeedback early on to establish the target kinematics of the targeted dysphagia training maneuver, then reinforces what was learned with sEMG. Mixed biofeedback training is being examined because it is more clinically feasible than VF biofeedback training, while still incorporating motor learning principles during part of the targeted dysphagia training.
The investigators hypothesize that VF training will reduce swallowing impairment more than mixed training, but mixed training will reduce swallowing impairment more than sEMG training. Additionally, this study will investigate whether adjuvant techniques known to augment motor training (non-invasive neural stimulation and explicit reward tested independently), will augment outcomes of each of the proposed training's. This innovative experimental design is significant because it investigates motor learning principles within an ideal training (VF biofeedback) as well as within a clinically feasible option (mixed biofeedback) to differentiate them from standard dysphagia training (sEMG), which has reported little to no improvements after intense motor training.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Device
    Other Names: TMS
    Intervention Desc: Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
    ARM 1: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 2: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 3: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 4: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 5: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
  • Transcranial direct current stimulation Device
    Other Names: tDCS
    Intervention Desc: Weak direct currents can be applied non-invasively, transcranially and painlessly. Such application leads to transient changes in corticomotor excitability that are fully reversible. There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
    ARM 1: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 2: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 3: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 4: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 5: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
  • Biofeedback Behavioral
    Intervention Desc: Motor learning is improvement in movement overtime, followed by retaining what was learned. To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback. Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention. Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers. Biofeedback training will occur 3 times.
    ARM 1: Kind: Experimental
    Label: Videofluoroscopy (VF) and Barium
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 2: Kind: Experimental
    Label: Surface Electromyography (sEMG)
    Description: This group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 3: Kind: Experimental
    Label: Mixed VF and sEMG
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 4: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 5: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 7: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 8: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 9: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 10: Kind: Experimental
    Label: VF with reward
    Description: This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
    ARM 11: Kind: Experimental
    Label: sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
    ARM 12: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
  • Financial Reward Behavioral
    Other Names: Explicit Reward
    Intervention Desc: Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward. Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning. Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training. Explicit reward (i.e. financial) incentivizes successful gains during motor training. Explicit reward has never been investigated in swallowing rehabilitation. However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.
    ARM 1: Kind: Experimental
    Label: VF with reward
    Description: This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
    ARM 2: Kind: Experimental
    Label: sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
    ARM 3: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
  • Volitional Laryngeal Vestibule Closure (vLVC) Behavioral
    Other Names: vLVC
    Intervention Desc: The volitional Laryngeal Vestibule Closure (vLVC), is a swallowing maneuver that emphasizes airway protection. Participants will be advised that they should not be able to breathe while performing the vLVC as the laryngeal vestibule should be closed. The biofeedback effects on vLVC training will be tested during 3 time periods: (1) Pre-training (establishing vLVC baseline performance), (2) Training (improving and generalizing vLVC skills); and (3) Post-training (generalizing and retaining skills when swallowing with no therapeutic technique, or natural swallowing).
    ARM 1: Kind: Experimental
    Label: Videofluoroscopy (VF) and Barium
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 2: Kind: Experimental
    Label: Surface Electromyography (sEMG)
    Description: This group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 3: Kind: Experimental
    Label: Mixed VF and sEMG
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 4: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 5: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 7: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 8: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 9: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 10: Kind: Experimental
    Label: VF with reward
    Description: This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
    ARM 11: Kind: Experimental
    Label: sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
    ARM 12: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
  • Videofluoroscopy (VF) and Barium Radiation
    Other Names: VF
    Intervention Desc: The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups. This will capture full resolution VF images of all subjects in real time in the lateral view. From the digital recording, image sequencing will be exported to an image processing computer system and archived. The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck. A simultaneously recorded time-code will facilitate frame-by-frame data analysis. VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
    ARM 1: Kind: Experimental
    Label: Videofluoroscopy (VF) and Barium
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 2: Kind: Experimental
    Label: Mixed VF and sEMG
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 3: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 4: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 5: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 7: Kind: Experimental
    Label: VF with reward
    Description: This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
    ARM 8: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
  • Submental Electromyography Device
    Other Names: sEMG
    Intervention Desc: Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
    ARM 1: Kind: Experimental
    Label: Surface Electromyography (sEMG)
    Description: This group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 2: Kind: Experimental
    Label: Mixed VF and sEMG
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the volitional Laryngeal Vestibule Closure (vLVC) swallowing maneuver.
    ARM 3: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 4: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 5: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 7: Kind: Experimental
    Label: sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
    ARM 8: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
  • Targeted dysphagia training maneuver Behavioral
    Intervention Desc: training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
    ARM 1: Kind: Experimental
    Label: Videofluoroscopy (VF) and Barium
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
    ARM 2: Kind: Experimental
    Label: Surface Electromyography (sEMG)
    Description: This group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
    ARM 3: Kind: Experimental
    Label: Mixed VF and sEMG
    Description: This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
    ARM 4: Kind: Experimental
    Label: VF with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 5: Kind: Experimental
    Label: sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 6: Kind: Experimental
    Label: Mixed VF, sEMG with anodal tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
    ARM 7: Kind: Experimental
    Label: VF with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 8: Kind: Experimental
    Label: sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 9: Kind: Experimental
    Label: Mixed VF, sEMG with sham tDCS
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
    ARM 10: Kind: Experimental
    Label: VF with reward
    Description: This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
    ARM 11: Kind: Experimental
    Label: sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
    ARM 12: Kind: Experimental
    Label: Mixed VF, sEMG with financial reward
    Description: This group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability Changes from 24 hrs, 1 week, 1 month No
Primary Laryngeal vestibule closure (LVC) biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month Changes from 24 hours, 1 week, and 1 month No
Primary Laryngeal vestibule closure (LVC) biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month Changes from 24 hours, 1 week, and 1 month No
Primary Laryngeal vestibule closure (LVC) biofeedback using both VF and sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month Changes from 24 hours, 1 week, and 1 month No
Secondary Training bolus vLVC maneuvers changes from 24 hours, 1 week, and 1 month Changes from 24 hours, 1 week, and 1 month No
Secondary Kinematic analysis will be performed on vLVC changes from 24 hours, 1 week, and 1 month. Changes from 24 hours, 1 week, and 1 month No
Secondary Training effect on financial reward analysis between 3 groups Changes from days 1, 2, and 3 No
Primary Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month Changes from 24 hours, 1 week, and 1 month
Primary Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month Changes from 24 hours, 1 week, and 1 month
Primary Targeted dysphagia training biofeedback using both VF and sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month Changes from 24 hours, 1 week, and 1 month
Secondary Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month Changes from 24 hours, 1 week, and 1 month
Secondary Kinematic analysis will be performed on targeted dysphagia maneuver changes from 24 hours, 1 week, and 1 month. Changes from 24 hours, 1 week, and 1 month

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