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| ID | Type | Description | Link |
|---|---|---|---|
| IK2RX003790 | U.S. NIH Grant/Contract | View source | |
| 1911101 | Other Identifier | Joseph Maxwell Cleland VA Medical Center |
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| Name | Class |
|---|---|
| Joseph Maxwell Cleland VA Medical Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frequency repetitive transcranial magnetic stimulation | Device | MagVenture MagPro X100 with MagOption |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline FSS score to 7 days after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John H Kindred | Contact | (970) 426-9350 | John.Kindred1@va.gov | |
| Christina Young | Contact | (404) 432-6111 | 207670 | christina.young3@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| John H Kindred | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Recruiting | Decatur | Georgia | 30033-4004 | United States |
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Participants will be blinded to their groups
| Sham repetitive transcranial magnetic stimulation | Device | MagVenture MagPro X100 with MagOption |
|
| 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. | 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. | Change from baseline MFIS score to 3 months after last treatment |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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