Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- High frequency repetitive transcranial magnetic stimulation
- Conditions
- Stroke
- Sponsor
- VA Office of Research and Development
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Fatigue Severity Scale (FSS) score
- Status
- Recruiting
- Last Updated
- 11 days ago
Overview
Brief Summary
This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. 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 transcranial 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.
Detailed Description
The PI for this trial transferred to the Atlanta VA Medical Center in Feb 2026. As a result, the trial was suspended at the original site and moved to the Atlanta area. Additional changes accompanying the site transfer include removing one arm of the study (an active comparator), leaving two arms: one with the active treatment and the other with a sham treatment. Eligibility criteria were also updated to be more ecologically relevant. Ethical approvals for the new site, Atlanta, were provided by the Emory University IRB.
Investigators
Eligibility Criteria
Inclusion Criteria
- •34 - 80 years of age
- •more than 6 months post-stroke
- •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
- •Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI)
- •Pregnancy
- •strokes within stimulation sites
- •Pregnancy
- •Severe hypertension (resting SBP \> 200, DBP \> 120)
Arms & Interventions
Real M1 High Frequency rTMS
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.
Intervention: High frequency repetitive transcranial magnetic stimulation
Sham rTMS
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.
Intervention: Sham repetitive transcranial magnetic stimulation
Outcomes
Primary Outcomes
Change in Fatigue Severity Scale (FSS) score
Time Frame: Change from baseline FSS score to 7 days after last treatment
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.
Secondary Outcomes
- Change in Modified Fatigue Impact Scale (MFIS) score(Change from baseline MFIS score to 3 months after last treatment)
- Change in Fatigue Severity Scale (FSS) score(Change from baseline FSS score to 3 months after last treatment)
- Change in Modified Fatigue Impact Scale (MFIS) score(Change from baseline MFIS score to 7 Days after last treatment)