Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning (TMS)
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|ClinicalTrials.gov Identifier: NCT03821337|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder||Device: repetitive Trans Magnetic Stimulation Device: Sham TMS||Not Applicable|
Opioid use disorders (OUDs) are common among Veterans. Despite the availability of opioid replacement therapies, many individuals continue to abuse opioids and relapse rates remain high. Veterans are nearly twice as likely to die from accidental opioid overdose than the general population. Approximately 60% of Veterans returning from the Middle East and more than 50% of older Veterans in the VA health care system have chronic pain. Further, post-traumatic stress disorder, a common comorbidity in the Veteran population, has been shown to negatively impact early engagement and retention of individuals in OUD treatment. As is the case with other substance use disorders, opioid craving is commonly described by abstinent patients whether or not they are stabilized on buprenorphine. Subsequently, a treatment that reduces pain and craving, while also improving early engagement and retention in treatment, would improve recovery from opioid addiction. Repetitive Transcranial Magnetic Stimulation (rTMS) is capable of non-invasively altering cortical function. rTMS is an FDA-approved treatment for major depressive disorder. Preliminary evidence suggests that rTMS can also reduce pain in chronic pain conditions and craving in substance use disorders. Single sessions of rTMS produce small temporary effects, while multiple sessions of rTMS result in larger, more durable effects. The investigators' group recently completed a blinded, sham-controlled crossover trial in non-treatment seeking OUD participants. A single session of rTMS reduced cue-induced craving and increased thermal pain thresholds. Given that multiple sessions of rTMS produce larger and more durable treatment effects than single sessions of rTMS, it follows that multiple treatment sessions applied to OUD patients may result in a clinically relevant reduction in pain and cue-induced craving, which could improve clinical and functional outcomes.
In this SPiRE pilot proposal, the investigators will perform a randomized, double-blind, sham-controlled trial delivering an accelerated course of rTMS to a cohort of OUD Veterans with chronic pain receiving treatment through the Ralph H. Johnson VA Medical Center Substance Treatment and Recovery program. The goal of this proposal is to evaluate the feasibility and acceptability of delivering rTMS to the dorsolateral pre-frontal cortex in Veterans with OUD and chronic pain. The investigators will also preliminarily explore the feasibility of evaluating potential outcome measurements in preparation for a larger trial, including abstinence, treatment retention, community reintegration and functional outcomes, pain, and opioid craving. Positive results from this pilot project will inform a future MERIT application and have the potential to significantly improve treatment outcomes in this difficult to treat Veteran population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, Randomized, Placebo-Controlled Trial|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An Exploratory Investigation Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning in Veterans With Opioid Use Disorder|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Participants will receive 18 sessions of active rTMS delivered at 120% rMT.
Device: repetitive Trans Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.
Other Name: rTMS
Placebo Comparator: Sham TMS
Participants will receive 18 sessions of sham rTMS delivered through an inactive coil.
Device: Sham TMS
Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland & Howard, 2014).
- Retention: Total number of rTMS sessions completed [ Time Frame: Through study completion, an average of 3 weeks ]Total number of rTMS sessions completed
- Tolerability: The total number of treatment emergent adverse events [ Time Frame: Through study completion, an average of 3 weeks ]The total number of treatment emergent adverse events.
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): NCT03821337
|Contact: Aimee L Mcrae-Clark, PharmD||(843) 792-5216||Aimee.McRae-Clark@va.gov|
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC||Recruiting|
|Charleston, South Carolina, United States, 29401-5799|
|Contact: Rutha A LaRue 843-789-6707 Rutha.Larue@va.gov|
|Contact: Sarah A Jackson, BA MA (843) 789-6700 email@example.com|
|Principal Investigator: Aimee L. Mcrae-Clark, PharmD|
|Principal Investigator:||Aimee L. Mcrae-Clark, PharmD||Ralph H. Johnson VA Medical Center, Charleston, SC|