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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 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 12 participants.
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
Interventions
- DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00886938
The ClinicalTrials.gov registry entry for NCT00886938 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study is the first listed.
NCT00886938 reports 0 study locations.
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.
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