StrokePhase 2NCT05584124
Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue
A Phase 2 study testing High frequency repetitive transcranial magnetic stimulation in people with Stroke and Stroke, Chronic, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 80 years
- Conditions the study is for
- Stroke, Stroke, Chronic, Fatigue
- What is being tested?
- High frequency repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2023to 29 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 6 months post-stroke
- Clinically present fatigue
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Brian J Cence, (843) 792-2668, brian.cence@va.gov
Alyssa Chesnutt, (843) 792-8171, hydar@musc.edu
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Medina O Bello, (404) 321-6111 ext. 206967, medina.bello@va.gov
Kevin Mammino, (404) 432-6111 ext. 205396, kevin.mammino@va.gov
About this study
Official title: Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study
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.
Read the 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.
- Conditions
- Stroke, Stroke, Chronic, Fatigue
- Being tested
- High frequency repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency repetitive transcranial magnetic stimulationDevice
MagVenture MagPro X100 with MagOption
Sham repetitive transcranial magnetic stimulationDevice
MagVenture MagPro X100 with MagOption
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline FSS score to 7 days after last treatment
Secondary outcomes (3)
Change in Modified Fatigue Impact Scale (MFIS) score
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.
Measured: Change from baseline MFIS score to 7 Days after last treatment
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.
Measured: Change from baseline FSS score to 3 months after last treatment
Change in Modified Fatigue Impact Scale (MFIS) score
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.
Measured: Change from baseline MFIS score to 3 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start10 Apr 2023
- Primary completion29 Oct 2027 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Joseph Maxwell Cleland VA Medical Center
- Responsible party
- Sponsor
- Investigators
- John H Kindred, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584124
- Sponsor's protocol ID
- N3790-W
- Other IDs
- IK2RX003790, 1911101
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study
- ClinicalTrials.gov ID
- NCT05584124
- Acronym / sponsor ID
- N3790-W
- Conditions
- Stroke, Stroke, Chronic, Fatigue
- Keywords
- non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Joseph Maxwell Cleland VA Medical Center
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real M1 High Frequency rTMS | Experimental | Device: High frequency repetitive transcranial magnetic stimulationParticipants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes. |
| Sham rTMS | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationParticipants 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. |
Who may qualify
- Ages
- 34 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 6 months post-stroke
- Clinically present fatigue
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency repetitive transcranial magnetic stimulationMagVenture MagPro X100 with MagOption | Device | Real M1 High Frequency rTMS |
| Sham repetitive transcranial magnetic stimulationMagVenture MagPro X100 with MagOption | Device | Sham rTMS |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John H Kindred principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High frequency repetitive transcranial magnetic stimulation in people with Stroke and Stroke, Chronic, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John H Kindred ((970) 426-9350, John.Kindred1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity Scale (FSS) score (time frame: Change from baseline FSS score to 7 days after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.