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NCT04156802 · ClinicalTrials.gov registry record · NA
Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain
A NA study of Chronic Pain and Opioid Use, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04156802 is a NA study of Chronic Pain and Opioid Use that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 38 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04156802, a NA study of Chronic Pain and Opioid Use, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
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 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 Studied
Interventions
- DEVICE Real TBS to the mPFC
- DEVICE Sham TBS to the mPFC
- DEVICE Real TBS to the MC
- DEVICE Sham TBS to the MC
Study Locations (1)
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2022-07-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04156802
The ClinicalTrials.gov registry entry for NCT04156802 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (95% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Chronic Pain appearing as the primary indexed condition, and to 4 interventions - of which Real TBS to the mPFC is the first listed.
NCT04156802 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04156802 about?
NCT04156802 is a clinical study titled "Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain". 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 narcoti...
What is the current status of trial NCT04156802?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2020-06-15. Estimated completion is 2022-07-06.
What conditions does trial NCT04156802 study?
This clinical trial studies the following conditions: Chronic Pain, Opioid Use, Pain, Chronic, Back Pain, Neuropathic Pain.
What interventions are being tested in trial NCT04156802?
The interventions under investigation include: Real TBS to the mPFC (DEVICE), Sham TBS to the mPFC (DEVICE), Real TBS to the MC (DEVICE), Sham TBS to the MC (DEVICE).
Who is sponsoring clinical trial NCT04156802?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04156802 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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