Condition category
Ear, Nose and Throat
Date applied
11/01/2005
Date assigned
04/04/2005
Last edited
05/10/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Elbert

ORCID ID

Contact details

Department of Psychology
University of Konstanz
P.O. Box D25
Konstanz
78434
Germany
+49 (0)7531 883363
Thomas.Elbert@uni-konstanz.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DFG/EL 101/20

Study information

Scientific title

Acronym

Tinnitus training

Study hypothesis

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

No ethics information provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Measured 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 measures

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)

Overall trial start date

01/06/2004

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2004

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Psychology
Konstanz
78434
Germany

Sponsor information

Organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53170
Germany
+49 (0)228 8851
postmaster@dfg.de

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes