Menu
Recruiting NCT05584124

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

Phase II Interventional Stroke Stroke, Chronic Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High frequency repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Stroke, Stroke, Chronic, Fatigue. Basic parameters: 34 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study

Overview

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.

Detailed 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.

Interventions

  • Device High frequency repetitive transcranial magnetic stimulation
    MagVenture MagPro X100 with MagOption
  • Device Sham repetitive transcranial magnetic stimulation
    MagVenture MagPro X100 with MagOption

Primary outcome measures

  • Change in Fatigue Severity Scale (FSS) score [Time frame: Change from baseline FSS score to 7 days after last treatment]
Secondary outcome measures (3)
  • Change in Modified Fatigue Impact Scale (MFIS) score [Time frame: Change from baseline MFIS score to 7 Days after last treatment]
  • Change in Fatigue Severity Scale (FSS) score [Time frame: Change from baseline FSS score to 3 months after last treatment]
  • Change in Modified Fatigue Impact Scale (MFIS) score [Time frame: Change from baseline MFIS score to 3 months after last treatment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur

Identifiers

NCT: NCT05584124 · N3790-W · IK2RX003790 · 1911101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗