Recruiting
Phase 2

rTMS

Sponsor:

VA Office of Research and Development

Code:

NCT05584124

Conditions

Stroke

Stroke, Chronic

Fatigue

Eligibility Criteria

Sex: All

Age: 34 - 70+

Healthy Volunteers: Not accepted

Interventions

High frequency repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

Study Details

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

Study ID

NCT05584124

Start date

Apr 10, 2023

Status verified date

Apr, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Oct 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 34 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real M1 High Frequency rTMS

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

sham comparator: Sham rTMS

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.

Interventions

High frequency repetitive transcranial magnetic stimulation

MagVenture MagPro X100 with MagOption

Sham repetitive transcranial magnetic stimulation

MagVenture MagPro X100 with MagOption

Primary outcome measure

  • Change in Fatigue Severity Scale (FSS) score [ Time Frame: Change from baseline FSS score to 7 days after last treatment ]

Central Contacts and Locations

Central contacts

John H Kindred

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

Christina Young

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

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Medina O Bello

404-321-6111medina.bello@va.gov

Kevin Mammino

(404) 432-6111kevin.mammino@va.gov

Principal Investigator:

John H Kindred

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-21.