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

NCT ID: NCT02383147

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-08-24

Brief Summary

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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

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Conditions

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Tinnitus, Subjective

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tomographic Neurofeedback (TONF)

15x Neurofeedback Trainings, 1-2 times per week

Group Type EXPERIMENTAL

Tomographic Neurofeedback

Intervention Type 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 (NTE)

15x Neurofeedback Trainings, 1-2 times per week

Group Type ACTIVE_COMPARATOR

Non Tomographic Neurofeedback

Intervention Type 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.

Interventions

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Tomographic 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

Intervention Type DEVICE

Non 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Kleinjung

Role: PRINCIPAL_INVESTIGATOR

ENT-Department, University Hospital Zurich

Locations

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University Hospital Zurich, Division of Otorhinolaryngology ORL

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. doi: 10.1016/S0079-6123(07)66046-4.

Reference Type BACKGROUND
PMID: 17956812 (View on PubMed)

Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17.

Reference Type BACKGROUND
PMID: 21592701 (View on PubMed)

Hartmann T, Lorenz I, Muller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23.

Reference Type BACKGROUND
PMID: 23700271 (View on PubMed)

Riha C, Guntensperger D, Oschwald J, Kleinjung T, Meyer M. Application of Latent Growth Curve modeling to predict individual trajectories during neurofeedback treatment for tinnitus. Prog Brain Res. 2021;263:109-136. doi: 10.1016/bs.pbr.2021.04.013. Epub 2021 May 20.

Reference Type DERIVED
PMID: 34243885 (View on PubMed)

Guntensperger D, Thuring C, Kleinjung T, Neff P, Meyer M. Investigating the Efficacy of an Individualized Alpha/Delta Neurofeedback Protocol in the Treatment of Chronic Tinnitus. Neural Plast. 2019 Mar 26;2019:3540898. doi: 10.1155/2019/3540898. eCollection 2019.

Reference Type DERIVED
PMID: 31049052 (View on PubMed)

Other Identifiers

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USZ-ORL-KT-001

Identifier Type: -

Identifier Source: org_study_id