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Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01261949
First received: December 16, 2010
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  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: Intervention 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Regensburg:

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

Secondary Outcome Measures:
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12 [ Time Frame: Baseline vs. all follow-up visits ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Beck Depression Inventory (BDI) [ Time Frame: Baseline vs. all follow-up visits ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL [ Time Frame: Baseline vs. all follow-up visits ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined low Frequency frontal and temporal rTMS
Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC
 Device: rTMS Intervention 1
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
Experimental: temporal low frequency rTMS
temporal low frequency rTMS of auditory cortex
 Device: Intervention 2
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (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 low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low 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: NCT01261949

Locations
Germany
University of Regensburg - Dept of Psychiatry
Regensburg, Bayern, Germany
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD University of Regensburg - Dep. 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: Berthold Langguth, MD, Ph.D., MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT01261949     History of Changes
Other Study ID Numbers: Uni-Reg-rTMS-Tinnitus-02
Study First Received: December 16, 2010
Last Updated: October 21, 2011
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 May 23, 2013