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NCT03544359 · ClinicalTrials.gov registry record · Early Phase 1

MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

A Early Phase 1 study of Tinnitus, Subjective, sponsored by Northwestern University.

Completed
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT03544359: Completed Early Phase 1 study of Tinnitus, Subjective, sponsored by Northwestern University.

NCT03544359 is a Early Phase 1 study of Tinnitus, Subjective that has completed, run by Northwestern University. The registered enrollment target is 20 participants, below the 193-participant average among 4 other Tinnitus, Subjective trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03544359, a Early Phase 1 study of Tinnitus, Subjective, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research is to understand how a neuromodulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic tinnitus measured with functional magnetic resonance imaging (fMRI). We hypothesize that multiple sessions of tES (5 consecutive days) will modulate: 1. Overall activity and local connectivity within brain regions near tES electrodes, and 2. Functional connectivity within brain networks associated with brain regions near tES electrodes. In exploratory analyses, we also measure the extent to which the hypothesized changes listed above a related to changes in tinnitus symptoms after tES.

Primary Outcome

Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI

Conditions Studied

Interventions

  • DEVICE Transcranial electrical stimulation (tES)

Study Locations (1)

Illinois

  • Center for Translational Imaging - Chicago

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-08-01
Est. Completion 2022-12-13
Phase Early Phase 1
Northwestern University

1,209 total trials

What the finished NCT03544359 record still lists

NCT03544359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 193-participant average among 4 other Tinnitus, Subjective trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Tinnitus, Subjective appearing as the primary indexed condition, and to 1 intervention - of which Transcranial electrical stimulation (tES) is the first listed.

NCT03544359 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT03544359 about?

NCT03544359 is a clinical study titled "MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus". The purpose of this research is to understand how a neuromodulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic tinnitus measured with functional magnetic resonance imaging (fMRI). We hypothesize that multiple sessions of tES (5 consecutive day...

What is the current status of trial NCT03544359?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2018-08-01. Estimated completion is 2022-12-13.

What conditions does trial NCT03544359 study?

This clinical trial studies the following conditions: Tinnitus, Subjective.

What interventions are being tested in trial NCT03544359?

The interventions under investigation include: Transcranial electrical stimulation (tES) (DEVICE).

Who is sponsoring clinical trial NCT03544359?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03544359 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03544359, the US trial registry maintained by the National Library of Medicine. NCT03544359 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.