- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01965028
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus (tRNS-tin)
March 4, 2016 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg
Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Regensburg, Germany
- University of Regensburg - Dept of Psychiatry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of bothersome, subjective chronic tinnitus
- Diagnosis: Duration of tinnitus more than 6 months
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial random noise stimulation (tRNS)
High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4
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High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
Time Frame: Week 12
|
Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame: Week 2
|
Week 2
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Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame: Week 4
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Week 4
|
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame: Week 12
|
Week 12
|
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame: Week 2
|
Week 2
|
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame: Week 4
|
Week 4
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Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame: Week 12
|
Week 12
|
Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame: Week 2
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Week 2
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Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame: Week 4
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Week 4
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Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame: Week 12
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Week 12
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Change in quality of life as measured by the WHOQoL-Bref
Time Frame: Week 2
|
Week 2
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Change in quality of life as measured by the WHOQoL-Bref
Time Frame: Week 4
|
Week 4
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Change in quality of life as measured by the WHOQoL-Bref
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, Ph.D., University of Regensburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
October 14, 2013
First Submitted That Met QC Criteria
October 14, 2013
First Posted (Estimate)
October 18, 2013
Study Record Updates
Last Update Posted (Estimate)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 4, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uni-Reg-tRNS01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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