Fatigue, Stroke, Stroke, Chronic
Conditions
Keywords
non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS
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.
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
MagVenture MagPro X100 with MagOption
DEVICESham repetitive transcranial magnetic stimulation
MagVenture MagPro X100 with MagOption
Sponsors
VA Office of Research and Development
Joseph Maxwell Cleland VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to their groups
Eligibility
Sex/Gender
ALL
Age
34 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Fatigue Impact Scale (MFIS) score | 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. |
| 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. |
Countries
United States
Contacts
CONTACTJohn H Kindred
CONTACTSaijleen Chawla, BS
PRINCIPAL_INVESTIGATORJohn H Kindred
Atlanta VA Medical and Rehab Center, Decatur, GA
Outcome results
None listed