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NCT05584124PHASE2Recruiting

Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.

VA Office of Research and Development

Start Date

4/10/2023

Completion Date

10/29/2027

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.

Eligibility Criteria

Age Range: 34 years to 80 years

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)

Interventions

DEVICE

High frequency repetitive transcranial magnetic stimulation

DEVICE

Sham repetitive transcranial magnetic stimulation

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Conditions

StrokeStroke, ChronicFatigue

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia 30033-4004

United States