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NCT00886938 · ClinicalTrials.gov registry record · Phase 2

rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study

A Phase 2 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target

NCT00886938: Completed Phase 2 study, sponsored by Washington University School of Medicine.

NCT00886938 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00886938, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study Summary

The neurological basis of tinnitus is uncertain when there is no evidence of damage to the peripheral auditory system. However, neuroimaging studies of tinnitus patients show hyperactivity in several cortical regions, especially the auditory cortices and middle temporal regions. A potentially promising treatment modality for tinnitus is repetitive transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas of the brain. When the magnetic device is placed on the skull, the resultant magnetic field passes through the skull and induces a small secondary current in the cortex. It has been hypothesized that the effect of the frequency used in rTMS differentially influences cortical activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation (10-20 Hz) increasing cortical activity. Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation of the left auditory cortex, an area that has been demonstrated to be hyperactive in tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however. Converging data implicate structures of the brain that are important for mood and attention as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment approach that targets these structures. A growing number of studies demonstrate involvement of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal cortex has been shown to increase the durability of the TPC stimulation. The independent effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that increasing the intensity and duration of stimulation has beneficial treatment effects. However, the field is new and more work is needed to assess the

Primary Outcome

Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.

Interventions

  • DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-06
Est. Completion 2010-08
Phase Phase 2

What the finished NCT00886938 record still lists

NCT00886938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study is the first listed.

NCT00886938 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00886938 about?

NCT00886938 is a clinical study titled "rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study". The neurological basis of tinnitus is uncertain when there is no evidence of damage to the peripheral auditory system. However, neuroimaging studies of tinnitus patients show hyperactivity in several cortical regions, especially the auditory cortices and middle temporal regions. A potentially promis...

What is the current status of trial NCT00886938?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2009-06. Estimated completion is 2010-08.

What interventions are being tested in trial NCT00886938?

The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study (DEVICE).

Who is sponsoring clinical trial NCT00886938?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00886938's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00886938, the US trial registry maintained by the National Library of Medicine. NCT00886938 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.