Use-induced reorganisation of the central auditory system in tinnitus

ISRCTN	ISRCTN80506415
DOI	https://doi.org/10.1186/ISRCTN80506415
Protocol serial number	DFG/EL 101/20
Sponsor	German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)
Funders	German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany), Eldith (Electro-Diagnostic & Therapeutic Systems GmbH, Ilmenau, Germany) lends a neurofeedback system (NEUROPRAX)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Use-induced reorganisation of the central auditory system in tinnitus
Study acronym	Tinnitus training
Study objectives	Chronic 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) studied	Chronic subjective tinnitus
Intervention	In 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 type	Other
Primary outcome measure(s)	Measured quantity of alpha and delta band frequency ranges (e.g. the alpha/delta ratio, or the delta band only) in the Electroencephalogram (EEG)
Key secondary outcome measure(s)	1. 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)
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	20
Total final enrolment	21
Key inclusion criteria	Two 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 criteria	Not provided at time of registration
Date of first enrolment	01/06/2004
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

Germany

Study participating centre

Department of Psychology

Konstanz
78434
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.