rTMS for Post-stroke Fatigue

Not Applicable

Recruiting

• Conditions: Stroke; Fatigue; Stroke, Chronic
• Interventions: Device: High frequency repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation

• Registration Number: NCT05584124
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-18
• Study Start: 2023-04-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2027-10-29
• Study Completion: 2027-10-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real LDLPFC High Frequency rTMS	High frequency repetitive transcranial magnetic stimulation	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.
Sham rTMS	Sham repetitive transcranial magnetic stimulation	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.
Real M1 High Frequency rTMS	High frequency repetitive transcranial magnetic stimulation	Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale (FSS) score	Change from baseline FSS score to 7 days after last treatment	The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue.

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale (FSS) score	Change from baseline FSS score to 3 months after last treatment	The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue.
Change in Modified Fatigue Impact Scale (MFIS) score	Change from baseline MFIS score to 3 months after last treatment	The Modified Fatigue Impact Scale (MFIS) is a Patient reported outcome assessing the impact of fatigue over the past four weeks. The questionnaire is comprised of 21 questions covering three domains (physical, cognitive, and psychosocial subscales). The assessment is graded on a 5 point Likert scale (0-4). The MFIS' range of scores is from 0-84 with higher scores indicating greater impact/worse fatigue. The range of scores for the physical, cognitive, and psychosocial subscales are 0-36, 0-40, and 0-8 respectively. Greater scores indicate greater/worse impact of fatigue.

Trial Locations

Locations (1)

Ralph H. Johnson VA Medical Center, Charleston, SC; 🇺🇸 Charleston, South Carolina, United States