RTMS for Treatment of Pain and Craving

NCT03310138 | Completed Phase 2 DMC

• 1 other identifier: 42186
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Chronic; Pain Acute

Keywords

treatment; brain stimulation

Outcome Measures

Primary Outcomes (1)

• Thermal pain threshold

  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.

  Day 1 versus Day 10

Study Arms (3)

Dorsolateral Prefrontal Cortex

ACTIVE COMPARATOR

Intervention: Real Transcranial Magnetic Stimulation Real Transcranial Magnetic Stimulation will be delivered to the left dorsolateral prefrontal cortex (10Hz, 110% of resting motor threshold) using a MagVenture MagPro B60 coil.

Device: Real Transcranial Magnetic Stimulation

Motor Cortex

ACTIVE COMPARATOR

Intervention: Real Transcranial Magnetic Stimulation Real Transcranial Magnetic Stimulation will be delivered to the left primary motor cortex (10Hz, 80% of resting motor threshold) using a MagVenture MagPro B60 coil.

Device: Real Transcranial Magnetic Stimulation

Sham stimulation

PLACEBO COMPARATOR

Intervention: Sham Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation will be delivered to the prefrontal cortex (10Hz, 110% of resting motor threshold) using the integrated sham system on the MagVenture MagPro B60 coil.

Device: Sham Transcranial Magnetic Stimulation

Interventions

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.

Also known as: TMS

Dorsolateral Prefrontal Cortex; Motor Cortex

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.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65
• currently prescribed prescription opiates for pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: July 6, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately after first publication of the results. This is estimated to be at the end of 2018.
• Access Criteria: Interested parties should contact the Principal Investigator directly

Locations

US (1)