Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain

Summary

Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is largely treated with opiate narcotics, much as was done in the Civil War. In addition to their high abuse liability and dependence potential, only 30 40% of chronic pain patients declare they receive satisfactory (\>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently, there is a critical need for new treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain.

The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) on self-reported pain and the brain s response to pain. This will be done in a cohort of patients recruited from the community as well as Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).

Conditions

• Chronic Pain
• Chronic Lower Back Pain
• Back Pain
• Opioid Use
• Opiate Dependence
• Pain, Chronic
• Neuropathic Pain
• Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

Real TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)

DEVICE

Sham TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.

DEVICE

Real TBS to the MC

This will be delivered with the Magventure Magpro system (double blinded).

DEVICE

Sham TBS to the MC

This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.

Sponsors & Collaborators

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Merideth A Addicott, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-15

Primary Completion

2022-07-06

Completion

2022-07-06

FDA Device

Yes

Countries

• United States

Study Locations