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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX003612 | U.S. NIH Grant/Contract | View source |
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There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. Exercise has improved PSP and associated symptoms such as mobility, fatigue, and quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique using electromagnetic induction for cortical neurostimulation. The use of rTMS has been explored shown to be effective in treating chronic PSP but is limited in effect duration. Our proposal will test the hypothesis that rTMS is feasible and safe to be paired with exercise. Additionally, the investigators believe a complementary effect can develop to enhance the neurostimulation duration of rTMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active rTMS+Exercise | Active Comparator | active rTMS |
|
| sham rTMS+Exercise | Sham Comparator | sham rTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS and exercise | Device | active |
| |
| Sham rTMS+Exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention | The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention. | From baseline to follow-up 30 days after last intervention |
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Inclusion Criteria:
Exclusion Criteria:
Moderate to severe cognitive impairment (Montreal Cognitive Assessment score <16/30)
Pre-stroke modified Rankin >2
History of seizures
Presence of any standard TMS or MRI contraindications (see human subjects)
Current diagnosis of DSM-5-defined bipolar disorder I, schizophrenia, schizoaffective disorder, or obsessive-compulsive disorder
Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 3 months (Participants must agree to abstain from illicit drugs during the study)
Increased risk of suicide that necessitates inpatient treatment or warrants additional therapy excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 3 months on Columbia Suicide Severity Rating Scale (C-SSRS)
Litigating for compensation for a psychiatric disorder
Current enrollment in another intervention trial for pain or stroke
Persons imprisoned, of minor age, diagnosed with terminal illness, or require surrogate for consent
Fails baseline exercise screening activities
Persistent post-stroke headaches not better accounted for by another diagnosis
Is unable to reliably attend intervention sessions i.e. planning to move, transportation issues
Neurological disorder pre- or post- stroke affecting subject's ability to follow study directions
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| Name | Affiliation | Role |
|---|---|---|
| Chen Lin, MD | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233-1927 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40343185 | Derived | Lin C, Morgan CJ, Fortenberry ELS, Androulakis XM, McGregor K. The safety and feasibility of a pilot randomized clinical trial using combined exercise and neurostimulation for post-stroke pain: the EXERT-Stroke study. Front Neurol. 2025 Apr 24;16:1524004. doi: 10.3389/fneur.2025.1524004. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS+Exercise | active rTMS Active rTMS and exercise: active |
| FG001 | Sham rTMS+Exercise | sham rTMS Sham rTMS+Exercise: sham |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS+Exercise | active rTMS Active rTMS and exercise: active |
| BG001 | Sham rTMS+Exercise | sham rTMS Sham rTMS+Exercise: sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention | The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention. | Only participants completing both the baseline and followup mRS assessment were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From baseline to follow-up 30 days after last intervention |
|
During the 10 intervention sessions over a 30-day period and a 1-month post-intervention follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS+Exercise | active rTMS Active rTMS and exercise: active | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Integrity Officer | Birmingham VA Medical Center | 2059338101 | 337436 | latanya.higginbottom@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2024 | Apr 29, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2024 | Jul 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014653 | Vascular Headaches |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Feasibility of a double-blind sham-controlled intervention
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Double-blind
| Combination Product |
sham |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sham rTMS+Exercise |
Patients with post-stroke headaches. Control arm: Sham rTMS and exercise arm. |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sham rTMS+Exercise | sham rTMS Sham rTMS+Exercise: sham | 0 | 4 | 0 | 4 | 0 | 4 |
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| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |