Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005523

Trial Description

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Title

Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

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Trial Acronym

Multisite rTMS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory
neural pathways contributing to the perception of phantom sounds.

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Brief Summary in Scientific Language

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 remains difficult. Most available therapies
focus on habituation rather than treating the cause. Tinnitus has been shown to be
associated with functional reorganization of auditory neural pathways and tonotopic maps in
the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic
Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the
treatment of tinnitus. Additionally, there is growing evidence that a neural network of both
auditory and non-auditory cortical areas is involved in the pathophysiology of chronic
subjective tinnitus. Targeting several core regions of this network by rTMS might constitute
a promising strategy to enhance treatment effects. A new multisite treatment protocol which
is supposed to have an effect on both auditory and non-auditory cortical areas will be
examined with regard to feasibility, safety and clinical efficacy in patients suffering from
chronic tinnitus in a controlled pilot trial.

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Organizational Data

  •   DRKS00005523
  •   2014/03/19
  •   2012/07/23
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT01663324  (ClinicalTrials.gov)
  •   Uni-Reg-multisite-rTMS-Tin-01  (University of Regensburg)
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Health Condition or Problem studied

  •   Chronic Tinnitus
  •   H93.1 -  Tinnitus
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Interventions/Observational Groups

  •   Device: rTMS intervention 1
  •   Device: rTMS intervention 2
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   [---]*
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12); time frame: Day 12
- Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12); time frame: Day 12

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Secondary Outcome

- Change of depressive symptoms as measured by the Major Depression Inventory (MDI); time frame: Day 12
- Change in quality of life as measured by the WHOQoL; time frame: Day 12
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"; time frame: Day 12
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90); time frame: Day 90
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale; time frame: Day 12
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale; time frame: Day 90
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale; time frame: Day 180
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI); time frame: Day 180
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI); time frame: Day 90
- Change in quality of life as measured by the WHOQoL; time frame: Day 90
- Change in quality of life as measured by the WHOQoL; time frame: Day 180
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"; time frame: Day 90
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"; time frame: Day 180
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180); time frame: Day 180
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller; time frame: Day 90
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller; time frame: Day 180

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/07/31
  •   50
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Diagnosis of subjective chronic tinnitus

- THI > 38

- Duration of tinnitus more than 6 months

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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

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Addresses

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    • University of Regensburg
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    • University of Regensburg, Dept of Psychiatry
    • Berthold Langguth, MD, Ph.D. 
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    • Berthold Langguth, MD, Ph.D. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.