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

Not Applicable

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Device: Tomographic Neurofeedback; Device: Non Tomographic Neurofeedback

• Registration Number: NCT02383147
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-18
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomographic Neurofeedback (TONF)	Tomographic Neurofeedback	15x Neurofeedback Trainings, 1-2 times per week
Non Tomographic Neurofeedback (NTE)	Non Tomographic Neurofeedback	15x Neurofeedback Trainings, 1-2 times per week

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Tinnitus symptoms assessed by questionnaires	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.
Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex	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
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.	at 1, 3, 6 month follow up	Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.

Trial Locations

Locations (1)

University Hospital Zurich, Division of Otorhinolaryngology ORL; 🇨🇭 Zurich, ZH, Switzerland