TMS and Exercise for Post-stroke Pain
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04672044 |
Recruitment Status :
Recruiting
First Posted : December 17, 2020
Last Update Posted : December 12, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Post-stroke Headache | Device: Active rTMS and exercise Combination Product: Sham rTMS+Exercise | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Feasibility of a double-blind sham-controlled intervention |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind |
Primary Purpose: | Treatment |
Official Title: | Feasibility of Combination Exercise and Neuromodulation Rehabilitation to Improve Post-stroke Chronic Pain |
Actual Study Start Date : | January 14, 2022 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: active rTMS+Exercise
active rTMS
|
Device: Active rTMS and exercise
active |
Sham Comparator: sham rTMS+Exercise
sham rTMS
|
Combination Product: Sham rTMS+Exercise
sham |
- Visual Analogue Scale for Pain [ Time Frame: through study completion, an average of 12 weeks ]The visual analog scale (VAS) is a validated, subjective measure for pain. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
- modified Rankin Scale [ Time Frame: through study completion, an average of 12 weeks ]
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Score Description:
0 No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672044
Contact: Chen Lin, MD | (205) 933-8101 | Chen.Lin@va.gov |
United States, Alabama | |
Birmingham VA Medical Center, Birmingham, AL | Recruiting |
Birmingham, Alabama, United States, 35233-1927 | |
Contact: Chen Lin, MD 205-933-8101 Chen.Lin@va.gov | |
Principal Investigator: Chen Lin, MD |
Principal Investigator: | Chen Lin, MD | Birmingham VA Medical Center, Birmingham, AL |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT04672044 |
Other Study ID Numbers: |
B3612-P I21RX003612 ( U.S. NIH Grant/Contract ) |
First Posted: | December 17, 2020 Key Record Dates |
Last Update Posted: | December 12, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Vascular Headaches post-stroke headache |
Stroke Headache Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pain Neurologic Manifestations |