Fostering Eating After Stroke With Transcranial Direct Current Stimulation "FEASt"

Recruiting

Phase N/A Results N/A

Update History

9 Mar '18
The description was updated.
New
Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. We herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. Our recent pilot study demonstrates that application of 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere is safe and feasible in the acute-subacute stroke phases and shows a promise in improving dysphagia, when combined with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. We will use our study cohort to examine important subject specific parameters which influence response to our proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject specific parameters to refine study inclusion criteria and aid in severity adjusted analysis.
Old
Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. We herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. Our recent pilot study demonstrates that application of 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere is safe and feasible in the acute-subacute stroke phases and shows a promise in improving dysphagia, when combined with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. We will use our study cohort to examine important subject specific parameters which influence response to our proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject specific parameters to refine study inclusion criteria and aid in severity adjusted analysis.
Trial was updated to "N/A."
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - 21 years or older in age since safety of non-invasive cortical stimulation in children. - Between 25 hours (day 2) to 144 (day 6) hours since stroke onset. - Unilateral hemispheric infarction (cortical or subcortical infarction) documented by imaging. - Moderate to severe dysphagia with a score of 4 or more on PAS Exclusion Criteria: - Prior history of swallowing difficulties. - Drowsiness or marked cognitive impairment that interferes with participation in swallowing maneuvers. - Unable to undergo an MRI due to claustrophobia or presence of electrically, magnetically or mechanically activated implant (including cardiac pacemaker), intracerebral vascular clips or any other electrically sensitive support system, metal in any part of the body, including metallic injury to eye, or pregnancy). - History of seizures or unexplained episodes of loss of consciousness.
Old
Inclusion Criteria: - 21 years or older in age since safety of non-invasive cortical stimulation in children. - Between 25 hours (day 2) to 144 (day 6) hours since stroke onset. - Unilateral hemispheric infarction (cortical or subcortical infarction) documented by imaging. - Moderate to severe dysphagia with a score of 4 or more on PAS Exclusion Criteria: - Prior history of swallowing difficulties. - Drowsiness or marked cognitive impairment that interferes with participation in swallowing maneuvers. - Unable to undergo an MRI due to claustrophobia or presence of electrically, magnetically or mechanically activated implant (including cardiac pacemaker), intracerebral vascular clips or any other electrically sensitive support system, metal in any part of the body, including metallic injury to eye, or pregnancy). - History of seizures or unexplained episodes of loss of consciousness.
18 Mar '14
A location was updated in Boston.
New
The overall status was updated to "Recruiting" at Beth Israel Deaconess Medical Center.