ICCAC-ToNF & Tinnitus

Tinnitus, Subjective Clinical Trial

— ICCAC  

Official title:

Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895047
• Other study ID #: 2018-01035
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 7, 2021

Study information

• Verified date: October 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• tomographic EEG Neurofeedback Training
EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex, the insula and the anterior cingulate cortex and deliver feedback for the patient

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Otorhinolaryngology ORL	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Tinnitus symptoms assessed by questionnaires	Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires	Time Frame: at 1, 3, 6 month follow up
Primary	Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex	EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods	Time Frame: at 1, 3, 6 month follow up
Secondary	brain structure (volume, surface area) of the three regions of interest as predictor for training success.	MRI measurement before training	Baseline (measurement before training)