Brief description of trial (Data source: BASEC)
Die Effektivität eines spezifischen multifokalen tomografischen Neurofeedback-Protokolls soll in Hinblick auf die Linderung Tinnitus-bedingten Leidensdrucks sowie der Minimierung der Tinnituswahrnehmung untersucht werden.
strukturelle MRT-Untersuchungen zur Ermittlung von neuroanatomischen Prädiktorvariablen für den Erfolg des Neurofeedback-Trainings.
Untersuchung der Effektivität von Hochfrequenter- versus Nicht-Hochfrequenter Behandlung. (2 Trainings pro Woche versus 1 Training pro Woche).
Bestimmung einer optimalen Sequenzierung der Trainingsprotokolls mittels gleichmässiger und randomisierter Aufteilung der Trainingssequenzen.
Health conditions investigated(Data source: BASEC)
chronischer Tinnitus (>6 Monate)
Health conditions
(Data source: WHO)
Tinnitus, Subjective
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
tomographisches EEG-Neurofeedback (TONF)
Interventions
(Data source: WHO)
Other: tomographic EEG Neurofeedback Training
Criteria for participation in trial
(Data source: BASEC)
- Für Alter normales Hören (Normaler Hörverlust von maximal 40 dB)
- zwischen 60 und 80 Jahre alt
- chronischer Tinnitus (über 6 Monate)
Exclusion criteria
(Data source: BASEC)
- schwere psychologische Erkrankungen (Alzheimer, Schizophrenie etc.)
- schwere körperliche Erkrankungen (Multiple Sklerose, Parkinson etc.)
- Cochlea-Implantate
- ferromagnetische Implantate
-Schwerhörigkeit über 40 dB
-Klaustrophobie
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- chronic tinnitus (>6 months)
- Age 40 to 80
- Informed Consent
- Fluent in German language
- mentally & physically fit
Exclusion Criteria:
- ferromagnetic implants
- cochlear implants
- average hearing loss over 50 dB
- claustrophoby
- addiction to alcohol or drugs
- intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
- acute suicidal
-
Further information on trial
Date trial registered
Mar 27, 2019
Incorporation of the first participant
Jul 1, 2018
Recruitment status
Completed
Academic title
(Data source: WHO)
Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Change from Baseline in Tinnitus symptoms assessed by questionnaires;Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
Secundary end point
(Data source: WHO)
ain structure (volume, surface area) of the three regions of interest as predictor for training success.
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Tobias Kleinjung
+41 (0)044 255 5854
tobias.kleinjung@usz.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
20.12.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01035
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