rTMS for Post-stroke Fatigue

Study Overview
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Brief Summary
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This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for people with post-stroke fatigue. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue, and other clinical characteristics related to mood and cognition, before and after participants receive rTMS.

Official Title
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Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study.

Conditions
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Stroke, Stroke, Chronic, Fatigue

Intervention / Treatment
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* Device: High frequency repetitive transcranial magnetic stimulation
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35 - 80 years of age more than 6 months post-stroke able to walk 10m unassisted Clinically present fatigue Exclusion Criteria: Contraindications to MRI/TMS/rTMS (e.g. implanted metal within the head, history of seizures) Inability to follow simple three-step instructions Multiple strokes on opposite hemispheres Cerebellar and/or brainstem strokes Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI) Comorbid psychological conditions (e.g. depression, anxiety, PTSD) strokes within stimulation sites Pregnancy Severe hypertension (resting SBP > 200, DBP > 120)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real M1 High Frequency rTMS<br>Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes. | Device: High frequency repetitive transcranial magnetic stimulation<br>* MAGSTIM Super Rapid2 Plus<br>|
| Experimental: Real LDLPFC High Frequency rTMS<br>Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left frontal part of their head for approximately 40 minutes. | Device: High frequency repetitive transcranial magnetic stimulation<br>* MAGSTIM Super Rapid2 Plus<br>|
| Sham Comparator: Sham rTMS<br>Participants will be randomly assigned to receive sham/placebo repetitive transcranial magnetic stimulation (rTMS) to the their head for approximately 40 minutes. This is a control condition. | Device: Sham repetitive transcranial magnetic stimulation<br>* MAGSTIM Super Rapid2 Plus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Severity Scale (FSS) score | The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue. | Change from baseline FSS score to 7 days after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Fatigue Impact Scale (MFIS) score | The Modified Fatigue Impact Scale (MFIS) is a Patient reported outcome assessing the impact of fatigue over the past four weeks. The questionnaire is comprised of 21 questions covering three domains (physical, cognitive, and psychosocial subscales). The assessment is graded on a 5 point Likert scale (0-4). The MFIS' range of scores is from 0-84 with higher scores indicating greater impact/worse fatigue. The range of scores for the physical, cognitive, and psychosocial subscales are 0-36, 0-40, and 0-8 respectively. Greater scores indicate greater/worse impact of fatigue. | Change from baseline MFIS score to 7 Days after last treatment | 
| Change in Fatigue Severity Scale (FSS) score | The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue. | Change from baseline FSS score to 3 months after last treatment | 
| Change in Modified Fatigue Impact Scale (MFIS) score | The Modified Fatigue Impact Scale (MFIS) is a Patient reported outcome assessing the impact of fatigue over the past four weeks. The questionnaire is comprised of 21 questions covering three domains (physical, cognitive, and psychosocial subscales). The assessment is graded on a 5 point Likert scale (0-4). The MFIS' range of scores is from 0-84 with higher scores indicating greater impact/worse fatigue. The range of scores for the physical, cognitive, and psychosocial subscales are 0-36, 0-40, and 0-8 respectively. Greater scores indicate greater/worse impact of fatigue. | Change from baseline MFIS score to 3 months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS