RTMS for Treatment of Pain and Craving

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.

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Key information

Conditions

Pain, Chronic Acute Pain Chronic Pain Neurologic Manifestations Pain Pain Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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:

change in pain sensitivity levels in the pain assessment task and
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 18-65
currently prescribed prescription opiates for pain

Exclusion criteria

documented history of seizures
unstable chronic medical illness
currently using any medications known to lower seizure risk
metal above the waist
pregnancy
history of a negative reaction to TMS

Treatment and study plan

Real Transcranial Magnetic Stimulation

Device

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.

Other names: TMS

Sham Transcranial Magnetic Stimulation

Device

The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

Primary outcomes

Thermal pain threshold

Time frame: Day 1 versus Day 10

Quantitative Sensory Testing will be used to measure each participant's thresholds for sensory detection of heat, painfulness, and tolerance. The investigators will test the hypothesis that Real TMS has a larger effect on thermal pain threshold following 10 days of TMS than sham TMS.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 16, 2017
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed