Study 6 of 33 for search of: "Tinnitus"
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Collaborative Tinnitus Research at Washington University (CTRWU)
This study is currently recruiting participants.
Verified by National Institute on Deafness and Other Communication Disorders (NIDCD), October 2008
Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT00567892
  Purpose

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. Each participant will initially receive either active rTMS or sham rTMS (placebo) for 2 weeks. After the 2 weeks, the participant will rest for 2 weeks. After the 2 week rest, the participant will then receive either active rTMS or sham rTMS, depending on what they received during the first 2 weeks. The order of the treatments received will be randomly selected and the participant will not be told which treatment they are receiving. Each participant will undergo magnetic resonance imaging (MRI) and positive emission tomography (PET) scanning of the brain at the beginning of the study and after each treatment.


Condition Intervention Phase
Subjective Tinnitus
Device: rTMS
Phase II
Phase III

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Collaborative Tinnitus Research at Washington University

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. rTMS: Experimental

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)

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)

2. Sham: Sham Comparator
Sham appears identical to and mimics sounds and sensations of active magnet.
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)


  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

On-line eligibility screening:

http://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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567892

Contacts
Contact: Joyce Nicklaus, RN, BSN 314.362.7508 nicklausj@ent.wustl.edu

Locations
United States, Missouri
Washington University Medical Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Joyce Nicklaus, RN,BSN     314-362-7508     nicklausj@ent.wustl.edu    
Principal Investigator: Jay F Piccirillo, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
  More Information

Clinical Outcomes Research Office at Washington University  This link exits the ClinicalTrials.gov site

Responsible Party: Washington University School of Medicine ( Jay F. Piccirillo )
Study ID Numbers: 07-0689, R01DC009095
Study First Received: December 3, 2007
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00567892  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
tinnitus
subjective tinnitus
therapy
repetitive transcranial magnetic stimulation
clinical trial

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009