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

December 8, 2022 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • Recruiting
        • University of Regensburg - Deptartment of Psychiatry
        • Contact:
        • Principal Investigator:
          • Berthold Langguth, MD, Ph.D.
        • Sub-Investigator:
          • Peter Kreuzer, MD, Dr.
        • Sub-Investigator:
          • Timm Pöppl, MD, Dr.
        • Sub-Investigator:
          • Martin Schecklmann, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of treatment responders
Time Frame: week 12
response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in tinnitus questionnaire
Time Frame: week 2, week 4, week 12
change in tinnitus questionnaire
week 2, week 4, week 12
change in tinnitus handicap inventory
Time Frame: week 2, week 4, week 12
change in tinnitus handicap inventory
week 2, week 4, week 12
change in tinnitus numeric rating scales
Time Frame: week 2, week 4, week 12
change in tinnitus numeric rating scales
week 2, week 4, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Berthold Langguth, University of Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Reg-tRNS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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