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NCT04203199 · ClinicalTrials.gov registry record · NA

H-coil TMS to Reduce Pain: A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil

A NA study, sponsored by Wake Forest University Health Sciences.

Terminated
Registry status
NA
Development phase
39
Enrollment target

NCT04203199: Clinical Trial NA study, sponsored by Wake Forest University Health Sciences.

NCT04203199 is a NA study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04203199, a NA study, was terminated before completion, sponsored by Wake Forest University Health Sciences.

TERMINATED
Registry status
NA
Development phase
39 participants
Enrollment target

Study Summary

Chronic pain is a serious public health problem with estimates as high as nearly half of the adult population experiencing some form of pain that lasts for more than 6 months. Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opiate analgesics, an escalating rate of opiate overdose deaths, and a resurgence of intravenous heroin use leading to total societal cost exceeding $55 billion. While opiates are effective at treating acute pain, tolerance to the analgesic effects develops quickly, leading to high abuse liability and dependence potential. Consequently, the development of a new, non-pharmacologic intervention to treat pain, such as repetitive transcranial magnetic stimulation (rTMS), which would provide analgesic benefit while also directly remodeling the neural circuitry responsible for cognitive control over opiate craving, would fill an increasingly urgent public health need.

Primary Outcome

Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MPFC TMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique which determines the sensation and pain thresholds of pressure. Painfulness ratings will be assessed and reported before and after rTMS.

Interventions

  • DEVICE Real rTMS to the mPFC using H7 Coil
  • DEVICE Real rTMS to the dlPFC using H1 Coil

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2022-01-18
Est. Completion 2022-10-06
Phase NA
Wake Forest University Health Sciences

1,140 total trials

Why NCT04203199 stopped before completion

NCT04203199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Real rTMS to the mPFC using H7 Coil is the first listed.

NCT04203199 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04203199 about?

NCT04203199 is a clinical study titled "H-coil TMS to Reduce Pain: A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil". Chronic pain is a serious public health problem with estimates as high as nearly half of the adult population experiencing some form of pain that lasts for more than 6 months. Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opi...

What is the current status of trial NCT04203199?

This trial is currently terminated. It is a NA study. The enrollment target is 39 participants. The study started on 2022-01-18. Estimated completion is 2022-10-06.

What interventions are being tested in trial NCT04203199?

The interventions under investigation include: Real rTMS to the mPFC using H7 Coil (DEVICE), Real rTMS to the dlPFC using H1 Coil (DEVICE).

Who is sponsoring clinical trial NCT04203199?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04203199's enrollment target sits among peer trials

39 1536th of 2000 higher than 463 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04203199, the US trial registry maintained by the National Library of Medicine. NCT04203199 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.