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NCT Number: NCT02383147

Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus

Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.

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Key information

Conditions

Tinnitus, Subjective Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Ear Diseases Graft vs Host Disease Hearing Disorders Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–75 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

  • Age 18-75
  • Chronic Tinnitus > 0.5 years
  • Informed Consent
  • Fluent in German language

Exclusion criteria

  • Psychological and neurological disorders other than tinnitus
  • Drug- or Alcohol abuse
  • Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake
  • Impairing hearing loss or Cochlea Implant

Treatment and study plan

Tomographic Neurofeedback

Device

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 and deliver feedback for the patient

Non Tomographic Neurofeedback

Device

EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.

Primary outcomes

  1. 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 tailored for Tinnitus and Quality of life.

  2. Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory 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 outcomes

  1. Difference in efficacy between Tomographic Neurofeedback (TONF) and Non Tomographic Neurofeedback (NTE) in treatment of tinnitus assessed by tinnitus questionnaires and frequency band EEG-activity measurements (3-4Hz and 8-12Hz) compared to Baseline.

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

    Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2015
Registry last updated
Oct 31, 2017

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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