Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

Completed

Phase N/A Results

Trial Description

Stroke is a leading cause of morbidity in the United States but identification of treatment strategies to improve outcome is limited by the incomplete understanding of the mechanisms of recovery. Motor cortex (M1) reorganization plays a major-role in the recovery of motor deficits post-stroke; hence the importance for further development of rehabilitative strategies that utilize this potential for recovery.
In Specific Aim 1, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned M1 of stroke patients.
In Specific Aim 2, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances structural cortical reorganization in lesioned M1 of stroke patients and to explore whether these structural changes are related to the training induced functional cortical reorganization.
The overall goal of this project is to determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization, thereby obtaining indirect evidence for the neuronal substrate underlying training related improvement and maintenance of motor function in stroke patients. This knowledge may have a substantial positive impact on treatment for stroke patients that may significantly improve recovery and could move the field of neuro-rehabilitation forward.

Detailed Description

Stroke is a leading cause of morbidity in the United States but identification of treatment strategies to improve outcome is limited by the incomplete understanding of the mechanisms of recovery. Motor cortex (M1) reorganization plays a major-role in the recovery of motor deficits post-stroke; hence the importance for further development of rehabilitative strategies that utilize this potential for recovery. Non-invasive cortical stimulation can enhance the beneficial effects of motor training on performance and functional plasticity of motor cortex. Among the different approaches used in these studies, Hebbian-type M1 stimulation is particularly intriguing, as it seems to be more effective when compared to random M1 stimulation. There is emerging evidence that motor training or cortical stimulation related improvement of function are associated with increases in the grey matter of targeted brain areas. While there is therefore some evidence supporting structural reorganization in human M1 in response to motor learning and cortical stimulation, the mechanisms underlying these changes and their relationship to functional plasticity are not known. A better understanding of the sequences of events is critical to development of optimal therapeutic interventions to improve recovery following stroke.
In Specific Aim 1, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned M1 of stroke patients.
In Specific Aim 2, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances structural cortical reorganization in lesioned M1 of stroke patients and to explore whether these structural changes are related to the training induced functional cortical reorganization.
The overall goal of this project is to determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization, thereby obtaining indirect evidence for the neuronal substrate underlying training related improvement and maintenance of motor function in stroke patients. This knowledge may have a substantial positive impact on treatment for stroke patients that may significantly improve recovery and could move the field of neuro-rehabilitation forward.

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) Other
    Intervention Desc: Training sessions for 5 days in a row
    ARM 1: Kind: Experimental
    Label: Stimulation
    ARM 2: Kind: Experimental
    Label: Hebbian-type Stimulation
    Description: Participants will be randomized to receive motor training with Hebbian-type stimulation.
  • Sham stimulation Other
    Intervention Desc: Sham stimulation
    ARM 1: Kind: Experimental
    Label: Sham
    ARM 2: Kind: Experimental
    Label: Sham Stimulation
    Description: Participants will be randomized to receive sham stimulation.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization 12 visits No
Primary Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks)
Secondary Mean Time to Completion for Jebsen Hand Function Test (JTT) Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Peak Acceleration of Wrist Extension Movements Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Reaction Time of Wrist Extension Movements Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Motor Activity Log (MAL) Score: Amount Subtest Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Motor Activity Log (MAL): How Well Subtest Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Wolf Motor Function Test (WMFT) Total Time Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score Baseline, Post-Training (1 Week), Post-Training (4 Weeks)
Secondary Mean Wolf Motor Function Test (WMFT) Grip Strength Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

Sponsors