Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-03 @ 2:00 AM
Study NCT ID:
NCT00567892
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2007-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Collaborative Tinnitus Research at Washington University
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Collaborative Tinnitus Research at Washington University
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTRWU
Brief Summary:
The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet and when placed against the scalp generates a small electrical field within the brain. Depending on the frequency of the stimulation, this electrical field can either decrease or increase the electrical excitability of the brain. In this study, low-frequency stimulation will be used, which is thought to decrease nerve activity. It is this electrical excitability of the brain that is thought to be responsible for tinnitus.
The hypothesis of this study is that rTMS can decrease the perception of tinnitus.
The hypothesis of this study is that rTMS can decrease the perception of tinnitus.
Detailed Description:
This will be a cross-over randomized trial. The order of the treatments received will be randomly selected and the participant will not be told which treatment they are receiving. Subjects will fall into one of the four treatment groups described below:
1. 2 weeks of active rTMS treatment followed by washout and then by 2 weeks sham
2. 2 weeks of sham followed by washout and then 2 weeks of active rTMS treatment
3. 4 weeks of active rTMS treatment followed by washout and then 4 weeks of sham
4. 4 weeks of sham followed by washout and then 4 weeks of active rTMS treatment
For the washout period between the two interventions, we will plan a minimum of 2 weeks to avoid the problem of carryover effects. Prior to starting the next intervention after the washout period, we will re-assess subject's tinnitus severity. To ensure no carryover effect, the washout period will be extended for those subjects whose tinnitus severity, as defined by the THI, is more than 20 points different than their baseline THI score.
1. 2 weeks of active rTMS treatment followed by washout and then by 2 weeks sham
2. 2 weeks of sham followed by washout and then 2 weeks of active rTMS treatment
3. 4 weeks of active rTMS treatment followed by washout and then 4 weeks of sham
4. 4 weeks of sham followed by washout and then 4 weeks of active rTMS treatment
For the washout period between the two interventions, we will plan a minimum of 2 weeks to avoid the problem of carryover effects. Prior to starting the next intervention after the washout period, we will re-assess subject's tinnitus severity. To ensure no carryover effect, the washout period will be extended for those subjects whose tinnitus severity, as defined by the THI, is more than 20 points different than their baseline THI score.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DC009095 | NIH | None | https://reporter.nih.gov/quic… | View |