Use-induced reorganisation of the central auditory system in tinnitus

ISRCTN ISRCTN80506415
DOI https://doi.org/10.1186/ISRCTN80506415
Secondary identifying numbers DFG/EL 101/20
Submission date
11/01/2005
Registration date
04/04/2005
Last edited
12/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Thomas Elbert
Scientific

Department of Psychology
University of Konstanz
P.O. Box D25
Konstanz
78434
Germany

Phone +49 (0)7531 883363
Email Thomas.Elbert@uni-konstanz.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleUse-induced reorganisation of the central auditory system in tinnitus
Study acronymTinnitus training
Study objectivesChronic subjective tinnitus is the perception of a (usually high-frequency) sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no cure. A broadly accepted view states that this symptom is not only reflected but caused by changes in the central nervous system. Based on a recent study (Weisz et al), we argue that tinnitus is related to changes in spontaneous activity patterns, that is an Alpha reduction and Delta enhancement (A/D)over temporal regions.

The enhancement of the A/D ratio, respectively the delta band - by means of several neurofeedback training protocols - results in ameliorations of the psychoacoustical (perceived loudness) and psychological (subjective distress) tinnitus variables.
Ethics approval(s)No ethics information provided at time of registration.
Health condition(s) or problem(s) studiedChronic subjective tinnitus
InterventionIn this trial we will investigate how different neurofeedback protocols affect distress variables and psychoacoustic measures. One group has to enhance alpha and reduce delta, the other group will only reduce delta. The neurofeedback training consists of ten sessions over three or four weeks.
Intervention typeOther
Primary outcome measureMeasured quantity of alpha and delta band frequency ranges (e.g. the alpha/delta ratio, or the delta band only) in the Electroencephalogram (EEG)
Secondary outcome measures1. Perceived loudness of the tinnitus (matched to a 1 kHz pure tone)
2. Tinnitus related distress (operationalised with a standard German questionnaire, Goebel et al., 1998)
Overall study start date01/06/2004
Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Total final enrolment21
Key inclusion criteriaTwo groups consisting of ten tinnitus sufferers each will be treated with a neurofeedback training. Any tinnitus sufferer can participate with no need to exclude subjects.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2004
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Psychology
Konstanz
78434
Germany

Sponsor information

German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)
Research organisation

Kennedyallee 40
Bonn
53170
Germany

Phone +49 (0)228 8851
Email postmaster@dfg.de
ROR logo "ROR" https://ror.org/018mejw64

Funders

Funder type

Research organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)

No information available

Eldith (Electro-Diagnostic & Therapeutic Systems GmbH, Ilmenau, Germany) lends a neurofeedback system (NEUROPRAX)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2007 12/01/2021 Yes No

Editorial Notes

12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.