NCT03576781

Developing rTMS Treatment Strategies for Pain in Opiate Dependence

Developing Brain Stimulation as a Treatment for Pain in Opiate Dependent Individuals: Parametric Assessment of 2 Evidence-based Strategies

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opiate analgesic, an escalating rate of opiate overdose deaths, and a resurgence of intravenous heroin use leading to total societal cost exceeding $55 billion. The struggle to break the addiction cycle is likely due to factors that affect neural circuits that govern craving and cognitive control. There is growing interest in the utilization of prefrontal cortex repetitive transcranial magnetic stimulation (rTMS) as a novel, non-invasive, non-pharmacologic approach to decreasing craving among chronic opiate users. At this early stage of development, however, it is unclear if the best TMS strategy is to (Strategy 1, Aim 1) increase activity in the dorsolateral prefrontal cortex, or (Strategy 2, Aim 2) decrease activity in the ventromedial prefrontal cortex. DESIGN: To parametrically evaluate these two promising treatment strategies, the investigators have developed a design where opiate dependent individuals and healthy controls will be randomized to receive either one placebo-like TMS treatment, or one of two real TMS treatments (DLPFC iTBS or MPFC cTBS). Participants with opiate dependence will be recruited from the local community, as well as the MUSC Center for Drug and Alcohol Programs (CDAP), the Ralph H. Johnson Substance Abuse Treatment Center and local pain clinics. Healthy controls will be recruited from the local community. Approved Study Team Members will visit the above mentioned clinics and community and talk with patients. Individuals who consent will receive interleaved TMS/BOLD imaging and our established MRI-based thermal pain paradigm immediately before and after rTMS. The investigators will also measure subjective pain and opiate craving ratings. The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative, new treatment option for pain in opiate dependent individuals.

Conditions

• Pain
• Chronic Pain
• Opioid Dependence
• Opioid Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-09
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2018-07-03
• Last updated: 2020-01-06

Locations

2 sites across 1 country: United States