NCT04672044CompletedPhase 1
TMS and Exercise for Post-stroke Pain
Feasibility of Combination Exercise and Neuromodulation Rehabilitation to Improve Post-stroke Chronic Pain
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 11 Dec 2020
- Start date
- 14 Jan 2022
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Stroke
- NCT number
- NCT04672044
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 14 Jan 2022 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Veterans who are in the process of applying for or receiving VA service-connected disability are eligible
Other illness
- Moderate to severe cognitive impairment (Montreal Cognitive Assessment score \<16/30)
- Pre-stroke modified Rankin \>2
- History of seizures
- 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)
- Current enrollment in another intervention trial for pain or stroke
- Persistent post-stroke headaches not better accounted for by another diagnosis
- Neurological disorder pre- or post- stroke affecting subject's ability to follow study directions
Age
- Persons imprisoned, of minor age, diagnosed with terminal illness, or require surrogate for consent
Other
- Presence of any standard TMS or MRI contraindications (see human subjects)
- Fails baseline exercise screening activities
- Is unable to reliably attend intervention sessions i.e. planning to move, transportation issues
Who the study is looking for
- Male or female Veteran of US military 19 years of age
- Signed informed consent
- Minimum of 3-months since time of stroke and medically stable
- Headache has persisted for \>3 months after stabilization of the stroke
- Ability to walk or tolerate recumbent cycle ergometry for 10 mins without assistance
- Stable pain medication regimen for 1 month prior to study
- Females of child-bearing potential (i.e. not postmenopausal or surgically sterile) must be using a medically acceptable method of birth control and should not be pregnant nor have plans for pregnancy or breastfeeding during the study
- Completed diagnostic, maximal graded exercise test including 12-lead ECG and indirect calorimetry (i.e. oxygen uptake, minute ventilation, respiratory exchange ratio, etc.)
- Minimum pain intensity of 30 on the Mechanical Visual Analogue Scale on average with pain symptoms.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
Related publications
- Pain Outcomes and Exercise Data from the EXERT-Stroke Pilot Clinical Trial on Post-Stroke Headaches.Restor Neurol Neurosci · 2026 · PMID 42720582
This page is information, not medical advice. Discuss any trial with your doctor.