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

NCT05584124 | Recruiting Phase 2 FDA Device

• 3 other identifiers: N3790-WIK2RX0037901911101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke, Chronic; Fatigue

Keywords

non-invasive brain stimulation; post-stroke fatigue; perception of fatigue; repetitive transcranial magnetic stimulation; rTMS

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Severity Scale (FSS) score

  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 from baseline FSS score to 7 days after last treatment

Secondary Outcomes (3)

• Change in Modified Fatigue Impact Scale (MFIS) score

  Change from baseline MFIS score to 7 Days after last treatment

• Change in Fatigue Severity Scale (FSS) score

  Change from baseline FSS score to 3 months after last treatment

• Change in Modified Fatigue Impact Scale (MFIS) score

  Change from baseline MFIS score to 3 months after last treatment

Study Arms (2)

Real M1 High Frequency rTMS

EXPERIMENTAL

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

Device: High frequency repetitive transcranial magnetic stimulation

Sham rTMS

SHAM COMPARATOR

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.

Device: Sham repetitive transcranial magnetic stimulation

Interventions

High frequency repetitive transcranial magnetic stimulation DEVICE

MagVenture MagPro X100 with MagOption

Real M1 High Frequency rTMS

Sham repetitive transcranial magnetic stimulation DEVICE

MagVenture MagPro X100 with MagOption

Sham rTMS

Eligibility Criteria

• Age: 34 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• more than 6 months post-stroke
• Clinically present fatigue

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Joseph Maxwell Cleland VA Medical Center: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John H Kindred

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John H Kindred

CONTACT

(970) 426-9350; John.Kindred1@va.gov

Christina Young

CONTACT

(404) 432-6111; christina.young3@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 18, 2022
• Study Start: April 10, 2023
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): October 29, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)