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Completed

NCT Number: NCT04672044

TMS and Exercise for Post-stroke Pain

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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
  • 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

Treatment and study plan

Active rTMS and exercise

Device

active

Sham rTMS+Exercise

Combination Product

sham

Primary outcomes

  1. Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Feasibility of Combination Exercise and Neuromodulation Rehabilitation to Improve Post-stroke Chronic Pain

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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