Collaborative Tinnitus Research at Washington University

NCT00567892 | Completed Phase 2 Results DMC

• 2 other identifiers: 07-0689R01DC009095
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Tinnitus

Keywords

tinnitus; subjective tinnitus; therapy; repetitive transcranial magnetic stimulation; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in THI (Tinnitus Handicap Inventory)

  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.

  baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)

Secondary Outcomes (1)

• 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)

Study Arms (2)

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

2. Sham rTMS

SHAM COMPARATOR

Sham rTMS appears identical to and mimics sounds and sensations of active magnet.

Device: rTMS

Interventions

rTMS DEVICE

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)

Also known as: Neuronetics 2100 device

1. rTMS; 2. Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Piccirillo JF, Garcia KS, Nicklaus J, Pierce K, Burton H, Vlassenko AG, Mintun M, Duddy D, Kallogjeri D, Spitznagel EL Jr. Low-frequency repetitive transcranial magnetic stimulation to the temporoparietal junction for tinnitus. Arch Otolaryngol Head Neck Surg. 2011 Mar;137(3):221-8. doi: 10.1001/archoto.2011.3.

  PMID: 21422304 RESULT

• Pierce KJ, Kallogjeri D, Piccirillo JF, Garcia KS, Nicklaus JE, Burton H. Effects of severe bothersome tinnitus on cognitive function measured with standardized tests. J Clin Exp Neuropsychol. 2012;34(2):126-34. doi: 10.1080/13803395.2011.623120. Epub 2011 Dec 14.

  PMID: 22168528 RESULT

• Burton H, Wineland A, Bhattacharya M, Nicklaus J, Garcia KS, Piccirillo JF. Altered networks in bothersome tinnitus: a functional connectivity study. BMC Neurosci. 2012 Jan 4;13:3. doi: 10.1186/1471-2202-13-3.

  PMID: 22217183 RESULT

• Piccirillo JF, Kallogjeri D, Nicklaus J, Wineland A, Spitznagel EL Jr, Vlassenko AG, Benzinger T, Mathews J, Garcia KS. Low-frequency repetitive transcranial magnetic stimulation to the temporoparietal junction for tinnitus: four-week stimulation trial. JAMA Otolaryngol Head Neck Surg. 2013 Apr;139(4):388-95. doi: 10.1001/jamaoto.2013.233.

  PMID: 23599075 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Excluding subjects with Beck Depression Index of above 14 we treated an exclusive group of the Very bothered tinnitus patients, which may not be representative of the tinnitus population as a whole.

Results Point of Contact

• Title: Dr. Jay F. Piccirillo
• Organization: Washington University

piccirilloj@ent.wustl.edu

314.362.8641

Study Officials

• Jay F Piccirillo, MD, CPI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Washington University School of Medicine

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 16, 2018
• Results First Posted: August 27, 2012

Record last verified: 2018-10

Locations

US (1)