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

Sponsor:	University of Regensburg
Information provided by:	University of Regensburg
ClinicalTrials.gov Identifier:	NCT00876720

Purpose

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.

Condition	Intervention
Tinnitus	Device: rTMS - Intervention 1 Device: rTMS - Intervention 2

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Official Title:	Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Hearing Disorders and Deafness Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Further study details as provided by University of Regensburg:

Primary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Combined frontal and temporal transcranial magnetic stimulation	Device: rTMS - Intervention 1 Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 20Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
2: Experimental Temporal transcranial magnetic stimulation	Device: rTMS - Intervention 2 Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876720

Contacts

Contact: Berthold Langguth, MD

+49 941 941 2099

berthold.langguth@medbo.de

Locations

Germany, Bavaria
University of Regensburg - Dept of Psychiatry	Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Berthold Langguth, MD +49 941 941 2099 berthold.langguth@medbo.de
Contact: Michael Landgrebe, MD +49 941 941 1226 michael.landgrebe@medbo.de
Principal Investigator: Berthold Langguth, MD
Sub-Investigator: Michael Landgrebe, MD

Sponsors and Collaborators

University of Regensburg

Investigators

Principal Investigator:

Berthold Langguth, MD

University of Regensburg-Dept of Psychiatry

More Information

Additional Information:

Tinnitus Research and Treatment Center at the University of Regensburg This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Regensburg, Dept of Psychiatry ( Berthold Langguth, MD )
Study ID Numbers:	Uni-Reg-rTMS-Tinnitus-01
Study First Received:	April 6, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00876720 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:

Tinnitus
chronic subjective tinnitus
transcranial magnetic stimulation
sensation disorders
hearing disorders

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

ClinicalTrials.gov processed this record on November 27, 2009