Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00011464

Trial Description

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Title

Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus

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Trial Acronym

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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 low-frequency 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. First
data suggest the use of transcranial random noise stimulation (tRNS) over both auditory
cortices as new and highly effective treatment. Low-frequency (lf; <100Hz) tRNS might be
highly effective in tackling hyper-synchronised cell assemblies. Daily lf-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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011464
  •   2017/05/08
  •   2015/11/24
  •   yes
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Secondary IDs

  •   NCT02615600  (ClinicalTrials.gov)
  •   Uni-Reg-tRNS02  (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: lf-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; time frame: week 12; response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)

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Secondary Outcome

- change in tinnitus questionnaire; time frame: week 2, week 4, week 12
- change in tinnitus handicap inventory; time frame: week 2, week 4, week 12
- change in tinnitus numeric rating scales; time frame: week 2, week 4, 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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  •   2015/11/30
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria:

- diagnosis of bothersome, subjective chronic tinnitus

- diagnosis: duration of tinnitus more than 6 months

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Exclusion Criteria

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 
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    • Berthold Langguth 
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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
  •   2016/12/12
* This entry means the parameter is not applicable or has not been set.