Imaging the Effects of rTMS on Chronic Pain

NCT02687360 | Terminated Results DMC FDA Device

• 1 other identifier: 7208
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is highly prevalent in patients with opioid use disorder on methadone maintenance therapy, and associated with problems related to psychosocial functioning, medical and psychiatric health, and substance craving and use. Neuroimaging has strongly correlated pain processing with the medial prefrontal and dorsal anterior cingulate cortices. This study will investigate the effects of repetitive transcranial magnetic stimulation (rTMS) using the H7 coil targeting these same brain areas for the treatment of chronic pain in patients on methadone maintenance therapy,and magnetic resonance imaging and spectroscopy (MRI/MRS) will be used to evaluate target engagement and mechanism.

Conditions

Chronic Pain; Opioid-use Disorder

Keywords

Methadone

Outcome Measures

Primary Outcomes (1)

• Feasibility: Ability to Recruit and to Have Participants Complete the Study

  Number of participants with chronic pain and comorbid psychiatric disorders who complete 60% of sessions.

  3 months

Study Arms (2)

Active rTMS stimulation

ACTIVE COMPARATOR

This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices.

Device: Active rTMS treatment

Sham rTMS stimulation

SHAM COMPARATOR

The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself.

Device: Sham rTMS treatment

Interventions

Active rTMS treatment DEVICE

In the active treatment, magnetic power output will be delivered to the participants through the coils.

Also known as: rTMS

Active rTMS stimulation

Sham rTMS treatment DEVICE

The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.

Sham rTMS stimulation

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic pain (back pain, osteoarthritis, complex regional pain syndrome, phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, or neuropathic facial pain).
• Able to give informed consent, and comply with study procedures.
• Opioid use disorder, moderate or severe.
• Enrolled in methadone maintenance treatment program for at least 2 months and at least 1 month on a stable dose of methadone (up to 300mg/day).

You may not qualify if:

• Medical conditions that preclude rTMS, including glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (CVA, TIA) any brain lesions (such multiple sclerosis),or seizure disorders.
• Meet DSM-5 criteria for major psychiatric illness, such as bipolar disorder, major depression (severe), suicidal thoughts, mania, or psychosis, that would interfere with participation or pose a risk for rTMS.
• Cognitive disorder.
• Currently pregnant.
• Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott-Raven press, NY 1998.14. This includes metal or shrapnel or bullet in the head or body, including metal shavings.
• Subjects with positive responses to the Transcranial Magnetic stimulation Adult safety screen (TASS).
• Currently taking a medication known to increase the risk of seizure.
• Subjects with claustrophobia making them unable to tolerate MRI scanning.
• Subjects involved in litigation regarding injury or worker's compensation benefits.
• Subjects with a diagnosis of vasculitis, peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Substance Treatment and Research Service (STARS)

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Diana Martinez
• Organization: Columbia Univeristy

dm437@cumc.columbia.edu

646-774-6160

Study Officials

• Diana Martinez, MD

  New York Sate Psychiatric Institute / Columbia University

  PRINCIPAL INVESTIGATOR

• Derek Blevins, MD

  New York State Psychiatric Institute / Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: February 22, 2016
• Study Start: September 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)