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