Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus

October 30, 2017 updated by: University of Zurich

A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus

Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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 Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Otorhinolaryngology ORL

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75
  • Chronic Tinnitus > 0.5 years
  • Informed Consent
  • Fluent in German language

Exclusion Criteria:

  • Psychological and neurological disorders other than tinnitus
  • Drug- or Alcohol abuse
  • Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake
  • Impairing hearing loss or Cochlea Implant

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tomographic Neurofeedback (TONF)
15x Neurofeedback Trainings, 1-2 times per week
Device: Tomographic Neurofeedback
EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex and deliver feedback for the patient
Active Comparator: Non Tomographic Neurofeedback (NTE)
15x Neurofeedback Trainings, 1-2 times per week
Device: Non Tomographic Neurofeedback
EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Tinnitus symptoms assessed by questionnaires
Time Frame: at 1, 3, 6 month follow up
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.
at 1, 3, 6 month follow up
Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex
Time Frame: at 1, 3, 6 month follow up
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
at 1, 3, 6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in efficacy between Tomographic Neurofeedback (TONF) and Non Tomographic Neurofeedback (NTE) in treatment of tinnitus assessed by tinnitus questionnaires and frequency band EEG-activity measurements (3-4Hz and 8-12Hz) compared to Baseline.
Time Frame: at 1, 3, 6 month follow up
Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.
at 1, 3, 6 month follow up

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Tobias Kleinjung, ENT-Department, University Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USZ-ORL-KT-001

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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