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NCT03681769 · ClinicalTrials.gov registry record · Early Phase 1
Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT03681769: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT03681769 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03681769, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MC rTMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique that determines thermal pain threshold.
Interventions
- DEVICE iTBS to the left dlPFC
- DEVICE Sham iTBS to the left dlPFC
- DEVICE cTBS to the mPFC
- DEVICE Sham cTBS to the mPFC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2021-03-19 |
| Phase | Early Phase 1 |
What the finished NCT03681769 record still lists
NCT03681769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which iTBS to the left dlPFC is the first listed.
NCT03681769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03681769 about?
NCT03681769 is a clinical study titled "Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent". 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...
What is the current status of trial NCT03681769?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2019-02-22. Estimated completion is 2021-03-19.
What interventions are being tested in trial NCT03681769?
The interventions under investigation include: iTBS to the left dlPFC (DEVICE), Sham iTBS to the left dlPFC (DEVICE), cTBS to the mPFC (DEVICE), Sham cTBS to the mPFC (DEVICE).
Who is sponsoring clinical trial NCT03681769?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03681769's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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