rTMS for Post-stroke Fatigue

VA Office of Research and Development

Status: Enrolling

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

Identifiers

NCT05584124

IK2RX003790 (U.S. NIH Grant/Contract)

00120805 (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 people with post-stroke fatigue. 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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 35 - 80 years of age
• more than 6 months post-stroke
• able to walk 10m unassisted
• 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
• Multiple strokes on opposite hemispheres
• Cerebellar and/or brainstem strokes
• Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI)
• Comorbid psychological conditions (e.g. depression, anxiety, PTSD)
• strokes within stimulation sites
• Pregnancy
• Severe hypertension (resting 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 3 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

Real LDLPFC High Frequency rTMS

Experimental group

Description:

Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left frontal part 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