Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005569

Trial Description

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Title

Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus

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Trial Acronym

tRNS-tin

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URL of the Trial

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Brief Summary in Lay Language

Stimulation of the left and right auditory cortex with daily transcranial random noise
stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.

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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. Tinnitus has been shown to be generated in the brain, as
a result of functional reorganization of auditory neural pathways and the central auditory
system. These changes are represented by hyper-activity and hyper-synchronicity in the
auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has
shown to be effective in the treatment of chronic tinnitus with moderate effect size.
Preliminary data presented on international conferences suggest the use of transcranial
random noise stimulation (tRNS) over both auditory cortices as new and highly effective
treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling
hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to
feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an
one-arm pilot trial.

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Organizational Data

  •   DRKS00005569
  •   2014/03/27
  •   2013/10/14
  •   yes
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Secondary IDs

  •   NCT01965028  (ClinicalTrials.gov)
  •   Uni-Reg-tRNS01  (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: Transcranial random noise stimulation (tRNS)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

- Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12); time frame: Week 12

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Secondary Outcome

- Change of tinnitus severity as measured by the Tinnitus Questionnaire; time frame: Week 2
- Change of tinnitus severity as measured by the Tinnitus Questionnaire; time frame: Week 4
- Change of tinnitus severity as measured by the Tinnitus Questionnaire; time frame: Week 12
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales; time frame: Week 2
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales; time frame: Week 4
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales; time frame: Week 12
- Change of depressive symptoms as measured by the Major Depression Inventory; time frame: Week 2
- Change of depressive symptoms as measured by the Major Depression Inventory; time frame: Week 4
- Change of depressive symptoms as measured by the Major Depression Inventory; time frame: Week 12
- Change in quality of life as measured by the WHOQoL-Bref; time frame: Week 2
- Change in quality of life as measured by the WHOQoL-Bref; time frame: Week 4
- Change in quality of life as measured by the WHOQoL-Bref; time frame: Week 12

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/10/31
  •   30
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Inclusion Criteria

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

- Diagnosis of bothersome, subjective chronic tinnitus

- Diagnosis: Duration of tinnitus more than 6 months

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Exclusion Criteria

- Objective tinnitus

- Irregular head shap below the electrodes

- Eczema on the head

- 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

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Addresses

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    • University of Regensburg
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    • University of Regensburg
    • 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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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.