Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

N/ACompletedNCT01965028

University of Regensburg30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Tinnitus

Interventions

Transcranial random noise stimulation (tRNS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Regensburg - Dept of Psychiatry

Regensburg, Germany

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

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

Data from ClinicalTrials.gov

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