Early Phase 1
N=22
Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
Chronic Pain · Opiate Dependence · Lower Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03681769 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Quantitative Pain Testing Following Active TMS Compared to Baseline — 1.4; .3 Change from Baseline (degrees C) — p=.83
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- iTBS to the left dlPFC (Device); Sham iTBS to the left dlPFC (Device); cTBS to the mPFC (Device); Sham cTBS to the mPFC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quantitative Pain Testing Following Active TMS Compared to Baseline |
1.4; .3 | .83 |
| SECONDARY Change in Patient Reported Pain and Discomfort |
5.3; 5.9 | .53 |
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 still largely treated with opiate narcotics, much as was done in the Civil War. In addition to the 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.
Aim 1. Evaluate repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: DLPFC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the Executive Control Network (ECN) when the patient is given instructions to 'control' the pain.
Aim 2. Evaluate Medial Prefrontal Cortex (MPFC) rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MPFC TMS will also attenuate the baseline brain response to pain (Pain Network activity) but will not effect the ECN or the Salience Network (SN) when the patient is given instructions to 'control' the pain.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 (to maximize participation)
- Currently 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. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine Carboxy-Tetrahydrocannabinol levels.
- Meets Diagnostic and Statistical Manual of Mental Disorders IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, 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 Attention Deficit Hyperactivity Disorder.
- Females of childbearing potential who are pregnant (by urine human chorionic gonadotropin level), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including driving under the influence related offenses).
- Does not have a stable living situation.
- Suffers from chronic migraines.
Data sourced from ClinicalTrials.gov (NCT03681769). 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.