Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

Not Applicable

Completed

• Conditions: Chronic Tinnitus
• Interventions: Device: Transcranial random noise stimulation (tRNS)

• Registration Number: NCT01965028
• Lead Sponsor: University of Regensburg

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of bothersome, subjective chronic tinnitus
• Diagnosis: Duration of tinnitus more than 6 months

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial random noise stimulation (tRNS)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 12
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 12

Trial Locations

Locations (1)

University of Regensburg - Dept of Psychiatry; 🇩🇪 Regensburg, Germany