NCT05584124 Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.
| NCT ID | NCT05584124 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-10 |
| Primary Completion | 2027-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-04-10 with a primary completion date of 2027-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
John H Kindred
PRINCIPAL INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA
Frequently Asked Questions
Who can join the NCT05584124 clinical trial?
This trial is open to participants of all sexes, aged 34 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05584124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05584124 currently recruiting?
Yes, NCT05584124 is actively recruiting participants. Contact the research team at John.Kindred1@va.gov for enrollment information.
Where is the NCT05584124 trial being conducted?
This trial is being conducted at Decatur, United States.
Who is sponsoring the NCT05584124 clinical trial?
NCT05584124 is sponsored by VA Office of Research and Development. The principal investigator is John H Kindred at Atlanta VA Medical and Rehab Center, Decatur, GA. The trial plans to enroll 60 participants.
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