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SNCTP000003659 | NCT03895047 | BASEC2018-01035

Neurofeedback -Training (oder EEG-basiertes Training zur Veränderung von Gehirnwellen) für ältere Personen mit chronischem Tinnitus

Data source: BASEC (Imported from 25.09.2020), WHO (Imported from 20.09.2020)
Changed: 20.09.2020
Disease category: Other

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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03895047

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03895047

Further information on trial

Date trial registered

27.03.2019

Incorporation of the first participant

01.07.2018

Recruitment status

Recruiting

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 frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex;Change from Baseline in Tinnitus symptoms assessed by questionnaires

Secundary end point (Data source: WHO)

brain 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

Contact for general information (Data source: WHO)

Tobias Kleinjung, Prof. Dr.
+41 44 255 58 55
tobias.kleinjung@usz.ch

Contact for scientific information (Data source: WHO)

Tobias Kleinjung, Prof. Dr.
+41 44 255 58 55
tobias.kleinjung@usz.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University of Zurich

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

Secondary ID (Data source: WHO)

2018-01035