Developing rTMS Treatment Strategies for Pain in Opiate Dependence

NCT03576781 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-01-06

No results posted yet for this study

Summary

The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.

Conditions

Interventions

DEVICE

Real iTBS

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)

DEVICE

Sham iTBS

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

DEVICE

Real cTBS

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

DEVICE

Sham cTBS

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

Sponsors & Collaborators

  • South Carolina Clinical & Translational Research Institute (SCTR)

    collaborator UNKNOWN
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Colleen A Hanlon, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2019-11-12
Completion
2019-11-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576781 on ClinicalTrials.gov