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Completed

NCT Number: NCT03895047

ICCAC-ToNF & Tinnitus

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.

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Division of Otorhinolaryngology ORL

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tomographic EEG Neurofeedback Training

Other

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

Primary outcomes

  1. Change from Baseline in Tinnitus symptoms assessed by questionnaires

    Time frame: Time Frame: at 1, 3, 6 month follow up

    Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires

  2. Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex

    Time frame: 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 outcomes

  1. brain structure (volume, surface area) of the three regions of interest as predictor for training success.

    Time frame: Baseline (measurement before training)

    MRI measurement before training

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People

Acronym: ICCAC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2019
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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