Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning (NCT03821337) | Clinical Trial Compass
TerminatedNot Applicable
Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning
Stopped: COVID-19 placed all Charleston VA projects on hold. Recently gained approval to open studies with COVID-19 precautions
United States1 participantsStarted 2019-10-11
Plain-language summary
Despite the availability of opioid replacement therapies, many opioid use disordered Veterans are not able to remain abstinent. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuromodulation technique with a consistent, rapidly expanding literature base reporting positive outcomes in substance using populations. This pilot application will investigate a novel multi-session rTMS paradigm to determine feasibility and tolerability of this intervention in opioid use disordered Veterans.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
* Participants must meet moderate to severe DSM-5 criteria for OUD. While individuals may also meet criteria for use disorders of other substances (with the exception of alcohol or benzodiazepines), they must identify opioids as their primary substance of abuse.
* Participants must report chronic pain for at least the past three months and have a Brief Pain Inventory score.
* Participants must be receiving treatment through the STAR program.
Exclusion Criteria:
* Participants who are pregnant.
* Participants with a history of/or current psychotic disorder.
* Participants with a history of dementia or other cognitive impairment.
* Participants with active suicidal ideation, or a suicide attempt within the past 90 days will be excluded.
* Participants with contraindications to receiving rTMS (including a history of seizures, or any implanted metal above the neck).
* Those with unstable general medical conditions.
* Those who are currently using naltrexone or tramadol.
* Those with current alcohol or benzodiazepine use disorders due to increased risk of seizure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retention: Total Number of rTMS Sessions Completed
Timeframe: Through study completion, an average of 3 weeks
2
Tolerability: The Total Number of Treatment Emergent Adverse Events
Timeframe: Through study completion, an average of 3 weeks