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

NCT02615600 | Recruiting DMC

• 1 other identifier: Uni-Reg-tRNS02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tinnitus

Keywords

tinnitus; transcranial random noise stimulation; tRNS; auditory cortex; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in tinnitus questionnaire

  week 2, week 4, week 12

• change in tinnitus handicap inventory

  week 2, week 4, week 12

• change in tinnitus numeric rating scales

  week 2, week 4, week 12

Study Arms (1)

lf-tRNS

EXPERIMENTAL

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

Device: lf-tRNS

Interventions

lf-tRNS DEVICE

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

lf-tRNS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of bothersome, subjective chronic tinnitus
• diagnosis: duration of tinnitus more than 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University of Regensburg - Deptartment of Psychiatry

Regensburg, 93053, Germany

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berthold Langguth

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berthold Langguth

CONTACT

berthold.langguth@medbo.de

Martin Schecklmann

CONTACT

martin.schecklmann@medbo.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: November 1, 2015
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)