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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02383147
Enrollment
52
Registered
2015-03-09
Start date
2015-03-31
Completion date
2017-08-24
Last updated
2017-10-31

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

Conditions

Tinnitus, Subjective

Keywords

Adult, Aged, Alpha Rhythm, Auditory Cortex, Chronic, Electroencephalography, Female, Humans, Male, Neurofeedback, Prospective Studies, Questionnaires, Tinnitus, Treatment Outcome

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.

Interventions

DEVICETomographic Neurofeedback

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

DEVICENon Tomographic Neurofeedback

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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Tinnitus symptoms assessed by questionnairesat 1, 3, 6 month follow upAssessement 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 cortexat 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
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 upInvestigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026