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Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.
NCT05584124 · VA Office of Research and Development
In plain English
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Official title
Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study
About this study
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.
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)
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-04-10
Estimated completion: 2027-10-29
Last updated: 2026-04-21
Interventions
Device: High frequency repetitive transcranial magnetic stimulationDevice: Sham repetitive transcranial magnetic stimulation
Primary outcomes
- • Change in Fatigue Severity Scale (FSS) score (Change from baseline FSS score to 7 days after last treatment)
Sponsor
VA Office of Research and Development · fed
With: Joseph Maxwell Cleland VA Medical Center
Contacts & investigators
ContactJohn H Kindred · contact · John.Kindred1@va.gov · (970) 426-9350
ContactChristina Young · contact · christina.young3@va.gov · (404) 432-6111
InvestigatorJohn H Kindred · principal_investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
All locations (1)
Atlanta VA Medical and Rehab Center, Decatur, GARecruiting
Decatur, Georgia, United States