ClinicalTrials.gg
RecruitingNCT05584124Updated Sep 14, 2026

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

A Phase 2 interventional study of High frequency repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation in Stroke, Stroke, Chronic and Fatigue, sponsored by VA Office of Research and Development. Recruiting at 2 sites in United States. Open to participants aged 34 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 7 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
34 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 87 studies in Stroke by VA Office of Research and Development — 13 open to participants now, 17 under way, none of them phase 3. Stroke · VA Office of Research and Development.

Planned enrollment
22nd of 79
60 · median 38
Started
2023
with 3 others
Phase 2
4 of 87
1 open now
Primary completion
2027-10
later than 13 of 16 live
Registered
78th of 87
by date

Among the 87 studies in Stroke by VA Office of Research and Development, this one is the 22nd largest by planned enrollment of the 79 interventional ones that give a count, is one of 4 that started in 2023, is one of 4 in phase 2, reaches primary completion later than 13 of the 16 other live ones, and was the 78th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

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Open to participants now

13 of the 87 studies in Stroke by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 34 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Stroke
  • Stroke, Chronic
  • Fatigue

Keywords

  • non-invasive brain stimulation
  • post-stroke fatigue
  • perception of fatigue
  • repetitive transcranial magnetic stimulation
  • rTMS
04

Who can participate

Ages eligible
34 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study 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.

    Device: High frequency repetitive transcranial magnetic stimulation

  • 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.

    Device: Sham repetitive transcranial magnetic stimulation

Interventions

  • DeviceHigh frequency repetitive transcranial magnetic stimulation

    MagVenture MagPro X100 with MagOption

  • DeviceSham repetitive transcranial magnetic stimulation

    MagVenture MagPro X100 with MagOption

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline FSS score to 7 days after last treatment

Secondary outcomes

  1. 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.

    Time frame: Change from baseline MFIS score to 7 Days after last treatment

  2. 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.

    Time frame: Change from baseline FSS score to 3 months after last treatment

  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.

    Time frame: Change from baseline MFIS score to 3 months after last treatment

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Oct 2027, 54 months after the start.

Of 113 non-industry phase 2 interventional studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 54 months is above that.

Counting every sponsor, half of 133 studies reached it within 40 months; a quarter within 24 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2022
First posted
Oct 18, 2022
StartActual
Apr 10, 2023
Primary completionEst.
Oct 29, 2027
CompletionEst.
Oct 29, 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05584124
Collaborators
Joseph Maxwell Cleland VA Medical Center
Responsible party
Sponsor
First posted
Oct 18, 2022
Start date
Apr 10, 2023
Primary completion
Oct 29, 2027 (estimated)
Completion
Oct 29, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

John H Kindred
Contact
John.Kindred1@va.gov
(970) 426-9350
Saijleen Chawla, BS
Contact
Saijleen.Chawla@va.gov
(470) 433-7967
John H Kindred
principal investigator · Atlanta VA Medical and Rehab Center, Decatur, GA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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