Clinical trial NCT02383147: Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus
Official title: A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: Adult
Aged
Alpha Rhythm
Auditory Cortex
Chronic
Electroencephalography
Female
Humans
Male
Neurofeedback
Prospective Studies
Questionnaires
Tinnitus
Treatment Outcome
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Tinnitus symptoms assessed by questionnaires
timeFrame: at 1, 3, 6 month follow up
measure: Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex
timeFrame: at 1, 3, 6 month follow up
Secondary outcomes:
measure: 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.
timeFrame: at 1, 3, 6 month follow up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Otorhinolaryngology ORL
state: ZH
Study officials:
affiliation: ENT-Department, University Hospital Zurich
name: Tobias Kleinjung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.