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

Status and phase: Enrolling; Phase 2

Conditions: Stroke, Chronic; Stroke; Fatigue

Treatments: Device: High frequency repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT05584124

IK2RX003790 (U.S. NIH Grant/Contract)

1911101 (Other Identifier)

N3790-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 34 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More than 6 months post-stroke
• Clinically present fatigue

Exclusion criteria

• Contraindications to magnetic resonance imaging (MRI)/transcranial magnetic stimulation (TMS)/repetitive transcranial magnetic stimulation (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 traumatic brain injury (TBI)
• Pregnancy
• Strokes within stimulation sites
• Pregnancy
• Severe hypertension (resting systolic blood pressure (SBP) > 200, DBP > 120)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Real M1 High Frequency rTMS

Experimental group

Description:

Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.

Treatment:

Device: High frequency repetitive transcranial magnetic stimulation

Sham rTMS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham repetitive transcranial magnetic stimulation