Collaborative Tinnitus Research at Washington University
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Subjective Tinnitus
- Sponsor
- Washington University School of Medicine
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Change in THI (Tinnitus Handicap Inventory)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Jay F. Piccirillo, MD
Professor, Washington University School of Medicine
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Men and women between the ages of 18 and 60 years.
- •Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater.
- •Tinnitus Handicap Inventory (THI) score of 38 or greater.
- •Subjects of child-bearing potential using an appropriate form of birth control acceptable to the research team and with a negative urine pregnancy test or undergone sterilization procedure.
- •Able to give informed consent.
- •Available for once daily therapy, during working hours, Mon.-Fri.
- •English-speaking.
Exclusion Criteria
- •Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone.
- •Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises).
- •History of seizures, history of loss of consciousness requiring medical care, any other CNS pathology that increases a subject's risk for treatment with rTMS.
- •Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for MRI scan.
- •Any contraindication for receiving FDG PET, as determined by established clinical criteria.
- •Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation.
- •Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated.
- •Patients with symptoms of depression as evidenced by a score of 14 or greater on the Beck Depression Inventory or, in the opinion of the psychiatric sub-investigator demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive Disorder.
- •Any psychiatric co-morbidity that, in the opinion of the psychiatric sub-investigator, may complicate the interpretation of study results.
- •Pregnancy
Outcomes
Primary Outcomes
Change in THI (Tinnitus Handicap Inventory)
Time Frame: baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)
Tinnitus Handicap Inventory (THI) is a measure of bother from tinnitus. THI is measured as a score in a scale ranging from 0=No bother to 100=Extremely Bothered. THI score post active rTMS treatment minus THI score pre active rTMS treatment will provide the change in THI score due to active treatment. THI score post rTMS sham minus THI score pre rTMS sham will provide change in THI due to sham. The difference of THI change due to active treatment minus THI change due to sham will provide the THI change that is our primary outcome measure.
Secondary Outcomes
- Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater(End of each treatment period (2 or 4 weeks))