Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus - Tabular View

Tracking Information

First Received Date ^ICMJE

April 6, 2009

Last Updated Date

April 27, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller [ Time Frame: Baseline, Day 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00876720 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Official Title ^ICMJE

Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Brief Summary

Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

Detailed Description

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment

Condition ^ICMJE

Tinnitus

Intervention ^ICMJE

Device: rTMS - Intervention 1
Device: rTMS - Intervention 2

Study Arms / Comparison Groups

Experimental: Combined frontal and temporal transcranial magnetic stimulation
Experimental: Temporal transcranial magnetic stimulation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of subjective chronic tinnitus
Duration of tinnitus more than 3 months

Exclusion Criteria:

Objective tinnitus
Treatable cause of the tinnitus
Involvement in other treatments for tinnitus at the same time
Clinically relevant psychiatric comorbidity
Clinically relevant unstable internal or neurological comorbidity
History of or evidence of significant brain malformation or neoplasm, head injury
Cerebral vascular events
Neurodegenerative disorder affecting the brain or prior brain surgery;
Metal objects in and around body that can not be removed
Pregnancy
Alcohol or drug abuse
Prior treatment with TMS

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Berthold Langguth, MD

+49 941 941 2099

berthold.langguth@medbo.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00876720

Responsible Party

Berthold Langguth, MD, University of Regensburg, Dept of Psychiatry

Study ID Numbers ^ICMJE

Uni-Reg-rTMS-Tinnitus-01

Study Sponsor ^ICMJE

University of Regensburg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Berthold Langguth, MD

University of Regensburg-Dept of Psychiatry

Information Provided By

University of Regensburg

Verification Date

April 2009

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