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: September 26, 2013
Last verified: September 2013

December 16, 2010
September 26, 2013
April 2009
December 2010   (final data collection date for primary outcome measure)
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller [ Time Frame: Baseline, Day 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261949 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tinnitus
  • Device: Combined frontal and temporal rTMS
    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)
  • Device: Temporal low frequency rTMS
    Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
  • Experimental: Combined frontal and temporal rTMS
    Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC
    Intervention: Device: Combined frontal and temporal rTMS
  • Experimental: Temporal low frequency rTMS
    temporal low frequency rTMS of auditory cortex
    Intervention: Device: Temporal low frequency rTMS
Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01261949
Uni-Reg-rTMS-Tinnitus-02
No
Berthold Langguth, MD, Ph.D., University of Regensburg
University of Regensburg
Not Provided
Principal Investigator: Berthold Langguth, MD University of Regensburg - Dep. of Psychiatry
University of Regensburg
September 2013

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