ICCAC-ToNF & Tinnitus
- Conditions
- Tinnitus, Subjective
- Registration Number
- NCT03895047
- Lead Sponsor
- University of Zurich
- Brief Summary
Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol.
Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness).
Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied.
Based on this multifocal (Insula, dorsal anterior cingulate cortex \& auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- chronic tinnitus (>6 months)
- Age 40 to 80
- Informed Consent
- Fluent in German language
- mentally & physically fit
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in Tinnitus symptoms assessed by questionnaires Time Frame: at 1, 3, 6 month follow up Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires
Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex Time Frame: at 1, 3, 6 month follow up EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
- Secondary Outcome Measures
Name Time Method brain structure (volume, surface area) of the three regions of interest as predictor for training success. Baseline (measurement before training) MRI measurement before training
Trial Locations
- Locations (1)
University Hospital Zurich, Division of Otorhinolaryngology ORL
🇨🇭Zurich, ZH, Switzerland
University Hospital Zurich, Division of Otorhinolaryngology ORL🇨🇭Zurich, ZH, Switzerland