We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615600
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Tinnitus Device: lf-tRNS Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Study Start Date : November 2015
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise Tinnitus

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. change in tinnitus questionnaire [ Time Frame: week 2, week 4, week 12 ]
    change in tinnitus questionnaire

  2. change in tinnitus handicap inventory [ Time Frame: week 2, week 4, week 12 ]
    change in tinnitus handicap inventory

  3. change in tinnitus numeric rating scales [ Time Frame: week 2, week 4, week 12 ]
    change in tinnitus numeric rating scales


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615600


Contacts
Layout table for location contacts
Contact: Berthold Langguth berthold.langguth@medbo.de
Contact: Martin Schecklmann martin.schecklmann@medbo.de

Locations
Layout table for location information
Germany
University of Regensburg - Deptartment of Psychiatry Recruiting
Regensburg, Germany, 93053
Contact: Martin Schecklmann, Dr.    +49 941 941 ext 2054    martin.schecklmann@medbo.de   
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.         
Sponsors and Collaborators
University of Regensburg
Investigators
Layout table for investigator information
Principal Investigator: Berthold Langguth University of Regensburg
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Berthold Langguth, MD, Ph.D., M.D., Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT02615600    
Other Study ID Numbers: Uni-Reg-tRNS02
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Berthold Langguth, MD, Ph.D., University of Regensburg:
tinnitus
transcranial random noise stimulation
tRNS
auditory cortex
non-invasive brain stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases