Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

NCT00329524 | Completed Results

• 1 other identifier: 51817
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus. This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.

Conditions

Tinnitus

Keywords

Tinnitus; TMS; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in PET Asymmetry Index

  Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx

  After active treatment week

Secondary Outcomes (2)

• Psychomotor Vigilance

  Immediately after treatment

• Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx

  immediately following active and sham TMS

Study Arms (1)

Active versus Sham Treatment

SHAM COMPARATOR

Subjects randomly assigned to active and sham TMS separated by one week interval.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.

Active versus Sham Treatment

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• right-handed subjects
• years of age
• debilitating unilaterial or bilateral tinnitus
• Experiencing the presence of phantom auditory preception for \>6 months
• Tinnitus Handicap Questionnaire score of \>30

You may not qualify if:

• significant neurological disease
• acoustic neuromas or glomus tumors
• active Meniere's disease
• profound hearing loss
• non English speaking
• personal or family history of epilepsy
• personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
• medications that lower seizure threshold and are contraindicated
• individuals who have been taking certain medications
• claustrophobia
• patients who do not exhibit significant cortical asymmetries on PET

Sponsors & Collaborators

• University of Arkansas: lead
• Tinnitus Research Consortium: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (2)

• Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34. doi: 10.1097/MLG.0b013e31802f4154.

  PMID: 17334317 RESULT

• Richter GT, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a case study. Laryngoscope. 2006 Oct;116(10):1867-72. doi: 10.1097/01.mlg.0000234936.82619.69.

  PMID: 17016213 RESULT

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Study was ended early and analysis was limited to only 5 subjects. A follow up study using a revised protocol is underway.

Results Point of Contact

• Title: John Dornhoffer, MD
• Organization: UAMS Department of Otolaryngology

dornhofferjohnl@uams.edu

501-686-7000

Study Officials

• John Dornhoffer, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 4, 2015
• Results First Posted: August 7, 2009

Record last verified: 2015-04

Locations

US (1)