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NCT Number: NCT05584124

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

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.

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Key information

Conditions

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

Age range

34 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than 6 months post-stroke
  • Clinically present fatigue

Exclusion criteria

  • Contraindications to magnetic resonance imaging (MRI)/transcranial magnetic stimulation (TMS)/repetitive transcranial magnetic stimulation (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 traumatic brain injury (TBI)
  • Pregnancy
  • Strokes within stimulation sites
  • Pregnancy
  • Severe hypertension (resting systolic blood pressure (SBP) > 200, DBP > 120)

Treatment and study plan

High frequency repetitive transcranial magnetic stimulation

Device

MagVenture MagPro X100 with MagOption

Sham repetitive transcranial magnetic stimulation

Device

MagVenture MagPro X100 with MagOption

Primary outcomes

  1. Change in Fatigue Severity Scale (FSS) score

    Time frame: 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 outcomes

  1. Change in Modified Fatigue Impact Scale (MFIS) score

    Time frame: Change from baseline MFIS score to 7 Days 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.

  2. Change in Fatigue Severity Scale (FSS) score

    Time frame: 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.

  3. Change in Modified Fatigue Impact Scale (MFIS) score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John H Kindred

CONTACT

[email protected]

(970) 426-9350

Saijleen Chawla, BS

CONTACT

[email protected]

(470) 433-7967

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Joseph Maxwell Cleland VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2022
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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