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

This study has been completed.
Sponsor:
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00876720
First received: April 6, 2009
Last updated: November 12, 2010
Last verified: November 2010
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Resource links provided by NLM:


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
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University of Regensburg - Dept of Psychiatry
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD University of Regensburg-Dept of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: Berthold Langguth, MD, University of Regensburg, Dept of Psychiatry
ClinicalTrials.gov Identifier: NCT00876720     History of Changes
Other Study ID Numbers: Uni-Reg-rTMS-Tinnitus-01
Study First Received: April 6, 2009
Last Updated: November 12, 2010
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:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014