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

NCT03821337 | Terminated Results DMC FDA Device

• 3 other identifiers: D3006-PRX003006Pro00084970
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Opioid use disorder

Outcome Measures

Primary Outcomes (2)

• Retention: Total Number of rTMS Sessions Completed

  Total number of rTMS sessions completed out of 6 sessions per day for three days over a three week period.

  Through study completion, an average of 3 weeks

• Tolerability: The Total Number of Treatment Emergent Adverse Events

  Number of adverse events experienced by Veterans receiving medication assisted treatment for opioid use disorder who undergo 18 sessions of active or sham rTMS.

  Through study completion, an average of 3 weeks

Study Arms (2)

rTMS

EXPERIMENTAL

Participants will receive 18 sessions of active rTMS delivered at 120% rMT.

Device: repetitive Trans Magnetic Stimulation

Sham TMS

PLACEBO COMPARATOR

Participants will receive 18 sessions of sham rTMS delivered through an inactive coil.

Device: Sham TMS

Interventions

repetitive Trans Magnetic Stimulation DEVICE

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.

Also known as: rTMS

rTMS

Sham TMS DEVICE

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).

Sham TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Program Manager
• Organization: VA Medical Center

lisa.nunn@va.gov

843-792-0476

Study Officials

• Aimee L. Mcrae-Clark, PharmD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double-blind, Randomized, Placebo-Controlled Trial

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 29, 2019
• Study Start: October 11, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)