Status:
COMPLETED
TMS and Exercise for Post-stroke Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Post-stroke Headache
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Veterans who are in the process of applying for or receiving VA service-connected disability are eligible
- 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
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04672044
Start Date
January 14 2022
End Date
December 30 2024
Last Update
June 15 2025
Active Locations (1)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927