rTMS for Treatment of Pain and Craving
Condition: Pain, Chronic; Pain Acute
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS)
      as a potential treatment for pain in individuals on prescription opioid medication.
      Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate
      specific brain areas in awake people (without the need for surgery, anesthetic, or other
      invasive procedures). This study will test whether 10 days of rTMS over the prefrontal cortex
      can produce a reduction in perception of pain and the desire to use opiates. TMS has been
      approved by the FDA as an investigational tool as well a therapy for depression.
    

Detailed description: 
      Individuals between the ages of 18 and 65 with current (past 3 months) prescription opioid
      use and chronic pain are being recruited. Participants will be screened on the telephone for
      major inclusion/exclusion criteria. Individuals meeting inclusion criteria based on the
      screening assessment will be set up for an appointment in the clinic. Participants will be
      instructed not to use alcohol, prescription opioids, or any other drugs on the day of their
      appointment. All study procedures will take place at the 30 Bee Street location of the Brain
      Stimulation Lab (BSL). The protocol contains 1 screening visit, 10 TMS visit, and 2 follow up
      visits. Individuals that are eligible following the screening visit will be randomized to
      receive real or sham TMS.

      On each TMS visit participants will undergo a single 20-minute session of 10Hz real or sham
      rTMS (on-time=5 secs, off-time=10 secs) at up to 110% of resting motor threshold using a
      MagVenture MagPro TMS machine.

      Primary outcomes will be:

        1. change in pain sensitivity levels in the pain assessment task and

        2. change in levels of opiate craving.

      The investigators will use analysis of variance models with group (real rTMS vs. sham) as the
      between-subjects factor and time (pre- to post-TMS) as a within-subject factor. The
      investigators will test the hypothesis that rTMS will result in significantly lower levels of
      reported pain sensitivity and craving, as compared to sham. Blind interim analyses of the
      data will be conducted when 50% of the sample has been accrued.
    

Intervention name(s): Real Transcranial Magnetic Stimulation; Sham Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons, which induces electrical currents in the brain. TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). In this study TMS is being delivered with the MagVenture MagPro B60 coil.; The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Other intervention name(s): TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: treatment; brain stimulation