Mode
Text Size
Log in / Sign up
N/A N=38 Randomized Double-blind Treatment

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

Chronic Pain · Chronic Lower Back Pain · Back Pain · Opioid Use · Opiate Dependence

Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Changes in Patient Reported Pain and Discomfort — 47; 13; -30; -18 percent change from baseline

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Real TBS to the mPFC (Device); Sham TBS to the mPFC (Device); Real TBS to the MC (Device); Sham TBS to the MC (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Patient Reported Pain and Discomfort
47; 13; -30; -18

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).

Eligibility Criteria

Inclusion Criteria

  • Age 18-75 (to maximize participation)
  • Can currently be using prescription opiates
  • Able to read and understand questionnaires and informed consent.
  • Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
  • Does not have metal objects in the head/neck.
  • Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
  • Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

Exclusion Criteria

  • Any psychoactive illicit substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen.
  • Meets DSM V criteria for current axis I disorders of obsessive-compulsive disorder, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
  • Has current suicidal ideation or homicidal ideation.
  • Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
  • Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  • Has current charges pending for a violent crime (not including DUI related offenses).
  • Does not have a stable living situation.
  • Suffers from chronic migraines.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04156802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search