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
Scientific
Department of Psychology
University of Konstanz
P.O. Box D25
Konstanz
78434
Germany
Phone | +49 (0)7531 883363 |
---|---|
Thomas.Elbert@uni-konstanz.de |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | 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 study start date | 01/06/2004 |
Completion date | 30/04/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
78434
Germany
Sponsor information
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)
Research organisation
Research organisation
Kennedyallee 40
Bonn
53170
Germany
Phone | +49 (0)228 8851 |
---|---|
postmaster@dfg.de | |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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.