Stroke Clinical Trial
Official title:
Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
Verified date | April 2022 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A substantial proportion of individuals are left with poor residual functioning of the affected arm after a stroke. This has a tremendous impact on the quality of life and the ability for stroke survivors to live independently. While exercise is considered essential to any rehabilitation program, its benefits are generally far from optimal because of the lack of proper dosing in terms of intensity. One way to tackle this problem is to develop better tools that could predict an individual's potential and then adjust the intensity of exercise accordingly. One such predicting tool exists and consists of using non-invasive brain stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of descending motor pathways originating from the brain. TMS consists of applying a magnetic wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of the current proposal is to use TMS to test the integrity of the motor pathway in chronic stroke survivors. The level of responses to TMS will be used to classify participants in terms of potential for recovery and then, to determine the optimal level of exercise. The study will also examine the effect of another non-invasive brain stimulation technique called transcranial Direct-Current Stimulation-tDCS to determine whether it can enhance the response to strength training exercise in the affected arm. Half of the participants will be trained with the tDCS on, while the other half will be trained with the stimulator off. The training program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be performed to determine the impact of the strength training intervention on participants. Overall, the proposed project is expected to have a positive and significant impact on stroke survivors' quality of life.
Status | Completed |
Enrollment | 90 |
Est. completion date | January 31, 2022 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. have had solely one supratentorial stroke 2. be in a chronic stroke phase (>6 months) Exclusion Criteria: 1. a significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale); 2. a significant pain intensity at the affected upper limb (= 4/10 on the Visual Analog Pain Scale); 3. a major sensory deficit (a score = 25/34 on the Nottingham Sensory Assessment); 4. a presence of hemineglect (> 70% of unshaded lines on the same side as the motor deficit on the Line Cancellation Test); 5. an apraxia (score >2.5 on the Alexander Test); 6. the presence of a neurological disorder other than a stroke; 7. concomitant orthopaedic problems at the affected upper limb and 8. any contraindication to TMS and/or tDCS. |
Country | Name | City | State |
---|---|---|---|
Canada | CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital | Laval | Quebec |
Canada | Bruyère Research Institute | Ottawa | Ontario |
Canada | Centre de recherche sur le vieillissement | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Brain Canada, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Fondation Vitae, Fonds de recherche du Québec, Jewish Rehabilitation Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Fugl-Meyer Stroke Assessment Scale | baseline and in the week after completion of the training program | ||
Primary | Change in peak-to-peak motor evoked potential amplitude and motor threshold elicited by transcranial magnetic stimulation | baseline and in the week after completion of the training program | ||
Secondary | Change in grip strength | baseline and in the week after completion of the training program | ||
Secondary | Change in Box and Block test | manual dexterity | baseline and in the week after completion of the training program | |
Secondary | Change in Motor Activity Log | participants' self-reported affected upper limb's level and quality of use in everyday activities | baseline and in the week after completion of the training program |
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