Collaborative Tinnitus Research at Washington University (CTRWU)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00567892
First received: December 3, 2007
Last updated: August 23, 2012
Last verified: August 2012

December 3, 2007
August 23, 2012
January 2008
June 2011   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
The primary outcome measure is defined as the change in the Tinnitus Handicap Inventory score between active rTMS and sham rTMS. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00567892 on ClinicalTrials.gov Archive Site
Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater [ Time Frame: End of each treatment period (2 or 4 weeks) ] [ Designated as safety issue: Yes ]

PGIC is a 7 point scale ranging from -3 to +3,with 0 meaning no change,negative values reporting worsening of symptoms(Tinnitus), and values of +1 or above reporting perceived improvement of Tinnitus.

PGIC score post active rTMS treatment treatment will provide subject's impression of change in tinnitue due to active treatment.PGIC score post rTMS sham will provide subject's impression of change in tinnitus due to sham. Number of subjects with scores of 1 or above are recorded to perceive improvement due to treatment of the corresponding study arm.

Participant's response to the Patient Global Impression of Change question to be completed at the end of each treatment arm. Participants will also be asked if they would continue treatment and if they would recommend this treatment to a friend. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Collaborative Tinnitus Research at Washington University
Collaborative Tinnitus Research at Washington University

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subjective Tinnitus
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)

Other Name: Neuronetics 2100 device
  • Experimental: 1. 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)

    Intervention: Device: rTMS
  • Sham Comparator: 2. Sham rTMS
    Sham rTMS appears identical to and mimics sounds and sensations of active magnet.
    Intervention: Device: rTMS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
June 2011
June 2011   (final data collection date for primary outcome measure)

On-line eligibility screening:

https://tinnitus.wustl.edu/

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
  • Currently breast-feeding
  • Previous treatment with rTMS
  • Patients with tinnitus related to Workman's Compensation claim or litigation-related event.
  • Patients with a history of diabetes.
  • Fasting glucose > 150mg/Dl.
  • Patients taking any medication(s), in the opinion of the investigator, that is(are) deemed to be etiologically related to the development of tinnitus.
  • Unable to elicit a motor threshold with rTMS.
  • A Mini-Mental Status Exam score less than 27.
  • Untreated or newly diagnosed hypertension, (systolic blood pressures above 140 mm or diastolic pressure above 90 mm).
  • Patients with a history of claustrophobia.
  • Inability to lay flat for 2 hours.
  • Active alcohol and/or drug dependence or history of alcohol and/or ETOH dependence within the last year.
  • Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.
  • Unable to provide informed consent.
  • Any exclusions from radiology screening for MRI or PET scanning.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567892
07-0689, R01DC009095
Yes
Jay F. Piccirillo, MD, Washington University School of Medicine
Washington University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Jay F Piccirillo, MD, CPI Washington University School of Medicine
Washington University School of Medicine
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP