Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Tinnitus

Intervention / Treatment
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* Device: Transcranial random noise stimulation (tRNS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial random noise stimulation (tRNS)<br>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 | Device: Transcranial random noise stimulation (tRNS)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus severity as measured by the Tinnitus Questionnaire |  | Week 2 | 
| Change of tinnitus severity as measured by the Tinnitus Questionnaire |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Questionnaire |  | Week 12 | 
| Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales |  | Week 2 | 
| Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales |  | Week 12 | 
| Change of depressive symptoms as measured by the Major Depression Inventory |  | Week 2 | 
| Change of depressive symptoms as measured by the Major Depression Inventory |  | Week 4 | 
| Change of depressive symptoms as measured by the Major Depression Inventory |  | Week 12 | 
| Change in quality of life as measured by the WHOQoL-Bref |  | Week 2 | 
| Change in quality of life as measured by the WHOQoL-Bref |  | Week 4 | 
| Change in quality of life as measured by the WHOQoL-Bref |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation