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

Chronic Tinnitus Clinical Trial

Official title:

Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02615600
• Other study ID #: Uni-Reg-tRNS02
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2025

Study information

• Verified date: December 2022
• Source: University of Regensburg
• Contact: Berthold Langguth
• Email: berthold.langguth[@]medbo.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	University of Regensburg - Deptartment of Psychiatry	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of treatment responders	response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)	week 12
Secondary	change in tinnitus questionnaire	change in tinnitus questionnaire	week 2, week 4, week 12
Secondary	change in tinnitus handicap inventory	change in tinnitus handicap inventory	week 2, week 4, week 12
Secondary	change in tinnitus numeric rating scales	change in tinnitus numeric rating scales	week 2, week 4, week 12