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NCT03621735 · ClinicalTrials.gov registry record · NA

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
100
Enrollment target

NCT03621735: Completed NA study, sponsored by University of Michigan.

NCT03621735 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03621735, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
100 participants
Enrollment target

Study Summary

The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.

Primary Outcome

Change in Tinnitus by the TinnTester software. Participants are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). These will be collected weekly during each treatment arm and washout. Absolute differences are averaged relative to baseline to determine loudness change. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six wee

Interventions

  • DEVICE Burst-SCS/sham SCS
  • DEVICE Sham SCS/Burst-SCS

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2018-11-01
Est. Completion 2022-07-06
Phase NA
University of Michigan

1,327 total trials

What the finished NCT03621735 record still lists

NCT03621735 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Burst-SCS/sham SCS is the first listed.

NCT03621735 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03621735 about?

NCT03621735 is a clinical study titled "Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts". The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a mod...

What is the current status of trial NCT03621735?

This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2018-11-01. Estimated completion is 2022-07-06.

What interventions are being tested in trial NCT03621735?

The interventions under investigation include: Burst-SCS/sham SCS (DEVICE), Sham SCS/Burst-SCS (DEVICE).

Who is sponsoring clinical trial NCT03621735?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03621735's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 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 NCT03621735, the US trial registry maintained by the National Library of Medicine. NCT03621735 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.