Skip to content

ICCAC-ToNF & Tinnitus

Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03895047
Acronym
ICCAC
Enrollment
36
Registered
2019-03-29
Start date
2018-07-01
Completion date
2021-06-07
Last updated
2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus, Subjective

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.

Interventions

OTHERtomographic 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

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Tinnitus symptoms assessed by questionnairesTime Frame: at 1, 3, 6 month follow upAssessement 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 cortexTime Frame: at 1, 3, 6 month follow upEEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods

Secondary

MeasureTime frameDescription
brain structure (volume, surface area) of the three regions of interest as predictor for training success.Baseline (measurement before training)MRI measurement before training

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026