Developing rTMS Treatment Strategies for Pain in Opiate Dependence
Condition: Pain; Chronic Pain; Opioid Dependence; Opioid Use
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Real iTBS; Sham iTBS; Real cTBS; Sham cTBS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key); 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.; This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Stimulation; Treatment