Effect of rTMS on Resting State Brain Activity in Tinnitus - Full Text View

Purpose

One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus loudness. The purpose of this study is to develop a new treatment option for tinnitus using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of alleviating or reducing the symptoms of tinnitus.

Condition	Intervention
Tinnitus	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - ACTIVE Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - SHAM

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of rTMS on Resting State Brain Activity in Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Change in tinnitus perception, as measured over time using a subjective visual analog rating scale [ Time Frame: At subject enrollment, before and after each active or sham rTMS session, inbetween active and sham treatments, and 2 months following the end of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Beck's Depression Inventory (BDI) [ Time Frame: BDI data obtained at the beginning and the end of each week of rTMS therapy ] [ Designated as safety issue: Yes ]
Change in Tinnitus Handicap Inventory (THI) [ Time Frame: THI data obtained at the beginning and the end of each week of rTMS treatment and at 2 month follow up ] [ Designated as safety issue: No ]
EEG measures of spectral power and coherence [ Time Frame: EEG recordings will be made at baseline, the end of each treatment week, and at 2 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Active/Sham Protocol All subjects complete the initial three weeks of rTMS sessions, which include 8 active sessions and 4 sham sessions. Subjects receive sham stimulation first to prevent carry forward effects of active treatment. Active and sham weeks are separated for each subject by an interval of no less than 21 days.	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - ACTIVE Active rTMS will be targeted according to the following decision tree: 1) to auditory cortex in the superior temporal gyrus opposite the ear with loudest tinnitus; 2) to the same region in the left temporal lobe. Active stimulation will be delivered at 110% of motor threshold (MT) at a frequency of 1 or 10 Hz for a total of 1800 magnetic pulses per session (and a total of 4 sessions per week of active rTMS therapy). Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - SHAM Sham rTMS will be targeted using a commercially available sham coil and delivered to the same site within the temporal lobe as active rTMS and in a manner identical to that for active rTMS except that scalp electrodes are used to stimulate the temporalis muscle electrically during sham stimulation to replicate the feel of active TMS.
Active Comparator: Maintenance rTMS Subjects who respond to either week of active rTMS have the option of participating in a maintenance rTMS program involving up to 8 additional sessions of therapy, each consisting of 3 days of rTMS treatment. Maintenance sessions will be scheduled with three weeks separating each treatment.	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - ACTIVE Active rTMS will be targeted according to the following decision tree: 1) to auditory cortex in the superior temporal gyrus opposite the ear with loudest tinnitus; 2) to the same region in the left temporal lobe. Active stimulation will be delivered at 110% of motor threshold (MT) at a frequency of 1 or 10 Hz for a total of 1800 magnetic pulses per session (and a total of 4 sessions per week of active rTMS therapy).

Arms

Assigned Interventions

Sham Comparator: Active/Sham Protocol

All subjects complete the initial three weeks of rTMS sessions, which include 8 active sessions and 4 sham sessions. Subjects receive sham stimulation first to prevent carry forward effects of active treatment. Active and sham weeks are separated for each subject by an interval of no less than 21 days.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - ACTIVE

Active rTMS will be targeted according to the following decision tree: 1) to auditory cortex in the superior temporal gyrus opposite the ear with loudest tinnitus; 2) to the same region in the left temporal lobe. Active stimulation will be delivered at 110% of motor threshold (MT) at a frequency of 1 or 10 Hz for a total of 1800 magnetic pulses per session (and a total of 4 sessions per week of active rTMS therapy).

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - SHAM

Sham rTMS will be targeted using a commercially available sham coil and delivered to the same site within the temporal lobe as active rTMS and in a manner identical to that for active rTMS except that scalp electrodes are used to stimulate the temporalis muscle electrically during sham stimulation to replicate the feel of active TMS.

Active Comparator: Maintenance rTMS

Subjects who respond to either week of active rTMS have the option of participating in a maintenance rTMS program involving up to 8 additional sessions of therapy, each consisting of 3 days of rTMS treatment. Maintenance sessions will be scheduled with three weeks separating each treatment.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) - ACTIVE

Active rTMS will be targeted according to the following decision tree: 1) to auditory cortex in the superior temporal gyrus opposite the ear with loudest tinnitus; 2) to the same region in the left temporal lobe. Active stimulation will be delivered at 110% of motor threshold (MT) at a frequency of 1 or 10 Hz for a total of 1800 magnetic pulses per session (and a total of 4 sessions per week of active rTMS therapy).

Detailed Description:

This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to 60 subjects, including males and females ages 19-89 years old and of all races, and with tinnitus severe enough to seek medical attention, will be enrolled in this study. All participants will be evaluated or medically reviewed by the study physician, Dr. Dornhoffer of the Hearing and Balance Clinic at UAMS, including a modified physical examination and hearing tests, prior to beginning therapy with rTMS in order to rule out any medically treatable causes of tinnitus. An MRI scan of the head may or may not be required, depending upon the results of this evaluation, in order to rule out specific middle ear pathologies.

This study will require participation in at least three weeks (4 weekdays per week) of rTMS sessions, including two active weeks and a sham (or placebo) week. There will be a three week washout period following each treatment week. At the completion of the three treatment weeks, subjects who have noticed an improvement in their tinnitus will have the option of participating in a maintenance rTMS program providing up to 8 additional weeks of treatment.

Eligibility

Ages Eligible for Study:	19 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of tinnitus established through a history and physical exam or review or records performed by the study physician
Subjects 19-89 years of age
Tinnitus present for at least 6 months and severe enough to seek medical attention
Subjects taking SSRI's (a class of anti-depressant medications)and benzodiazepines (a class of anti-anxiety medications) for depression or anxiety related to tinnitus must be stable on their current dose for at least 3 months and must not alter their dose or medication during their involvement with this study
Subjects must agree to avoid consuming alcohol within 72 hours of each rTMS session
Female subjects of childbearing potential must demonstrate a negative pregnancy test during their initial clinic visit and must agree to use effective contraception during their participation in this study
Subjects must sign an informed consent and agree to comply with study and follow-up procedures, including completion of all necessary questionnaires and testing, as well as, being video-recorded for safety purposes during rTMS sessions
Subjects must speak and comprehend English adequately to understand and complete any study-related instructions and questionnaires

Exclusion Criteria:

Subjects or any of their 1st-degree relatives must not have been diagnosed with epilepsy
Subjects must not have a history of seizure disorder or migraines
Subjects must not have any history of a brain aneurysm, stroke, previous cranial neurosurgery, acoustic neuroma, glomus tumor, active Menniere's Disease, profound hearing loss (greater than 90 dB at 4000 Hz), or any major neurological or psychiatric disorders (excluding depression or anxiety related to tinnitus)
Subjects must not have any history of a head injury that resulted in a loss of consciousness for more than 10 minutes
Subjects must not have any metal implants or devices in the head or neck or a pacemaker.
Subjects must not have severe claustrophobia if they are to have an MRI. Significant abnormalities must not be present on acquired or existing CT or MRI image of the head.
Subjects must not be pregnant or refuse to utilize effective contraception during their participation in this study
Subjects must not have any history of Bipolar Disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926237

Contacts

Contact: Mark S Mennemeier, PhD		msmennemeier@uams.edu
Contact: Ginger Brown, MA		GJBrown@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Sub-Investigator: John Dornhoffer, MD
Principal Investigator: Mark Mennemeier, PhD

Sponsors and Collaborators

University of Arkansas

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Mark Mennemeier, PhD

UAMS Department of Neurosciences

More Information

No publications provided

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00926237 History of Changes
Other Study ID Numbers:	109033
Study First Received:	June 19, 2009
Last Updated:	May 8, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Tinnitus
Transcranial Magnetic Stimulation
TMS
rTMS

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013