NCT00567892

Collaborative Tinnitus Research at Washington University

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Subjective Tinnitus

Interventions

Type	Name	Description
DEVICE	rTMS	Stimulation Settings: Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains)

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-12-05
• Last updated: 2018-11-16
• Results posted: 2012-08-27

Locations

1 site across 1 country: United States