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Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning (TMS)

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ClinicalTrials.gov Identifier: NCT03821337
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Device: repetitive Trans Magnetic Stimulation Device: Sham TMS Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, Randomized, Placebo-Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Arm Intervention/treatment
Experimental: rTMS
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).




Primary Outcome Measures :
  1. Retention: Total number of rTMS sessions completed [ Time Frame: Through study completion, an average of 3 weeks ]
    Total number of rTMS sessions completed

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Aimee L Mcrae-Clark, PharmD (843) 792-5216 Aimee.McRae-Clark@va.gov

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Not yet recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Rutha A LaRue    843-789-6713    Rutha.Larue@va.gov   
Contact: Sarah A Jackson, BA MA    (843) 789-6700    sarah.jackson@va.gov   
Principal Investigator: Aimee L. Mcrae-Clark, PharmD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Aimee L. Mcrae-Clark, PharmD Ralph H. Johnson VA Medical Center, Charleston, SC

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03821337     History of Changes
Other Study ID Numbers: D3006-P
RX003006 ( Other Grant/Funding Number: Department of Veterans Affairs )
Pro00084970 ( Other Identifier: MUSC IRB )
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by VA Office of Research and Development:
Opioid use disorder