Developing rTMS Treatment Strategies for Pain in Opiate Dependence
CompletedEarly phase 1NCT03576781
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.
Study details
- Official title
- Developing Brain Stimulation as a Treatment for Pain in Opiate Dependent Individuals: Parametric Assessment of 2 Evidence-based Strategies
- Interventions
- Device: Real iTBS
- Device: Sham iTBS
- Device: Real cTBS
- Device: Sham cTBS
- Sponsor
- Medical University of South Carolina
- Collaborators
- South Carolina Clinical & Translational Research Institute (SCTR)
- Start date
- 2017-02-09
- Primary completion
- 2019-11-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Able to read and understand questionnaires and informed consent. 2. Able to read and understand questionnaires and informed consent. 3. Lives within 50 miles of the study site. 4. 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) 5. Does not have metal objects in the head/neck. 6. 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. 7. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms. Exclusion Criteria: 1. 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 THC levels. 2. Meets DSM 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. 3. Has current suicidal ideation or homicidal ideation. 4. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD. 5. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. 6. Has current charges pending for a violent crime (not including DUI related offenses). 7. Does not have a stable living situation. 8. Suffers from chronic migraines.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03576781