Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)

Not Applicable

Recruiting

• Conditions: Chronic Tinnitus
• Interventions: Device: lf-tRNS

• Registration Number: NCT02615600
• Lead Sponsor: University of Regensburg

Brief Summary

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.

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. 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-09
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lf-tRNS	lf-tRNS	Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): \<100Hz, 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	week 12	response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)

Secondary Outcome Measures

Name	Time	Method
change in tinnitus questionnaire	week 2, week 4, week 12	change in tinnitus questionnaire
change in tinnitus numeric rating scales	week 2, week 4, week 12	change in tinnitus numeric rating scales
change in tinnitus handicap inventory	week 2, week 4, week 12	change in tinnitus handicap inventory

Trial Locations

Locations (1)

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