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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2017
CompletedOctober 31, 2017
October 1, 2017
2.5 years
February 18, 2015
October 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Tinnitus symptoms assessed by questionnaires
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.
at 1, 3, 6 month follow up
Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
at 1, 3, 6 month follow up
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.
at 1, 3, 6 month follow up
Study Arms (2)
Tomographic Neurofeedback (TONF)
EXPERIMENTAL15x Neurofeedback Trainings, 1-2 times per week
Non Tomographic Neurofeedback (NTE)
ACTIVE COMPARATOR15x Neurofeedback Trainings, 1-2 times per week
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Age 18-75
- Chronic Tinnitus \> 0.5 years
- Informed Consent
- Fluent in German language
You may not qualify if:
- Psychological and neurological disorders other than tinnitus
- Drug- or Alcohol abuse
- Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake
- Impairing hearing loss or Cochlea Implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Otorhinolaryngology ORL
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (5)
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.
PMID: 17956812BACKGROUNDCrocetti 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.
PMID: 21592701BACKGROUNDHartmann 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.
PMID: 23700271BACKGROUNDRiha 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.
PMID: 34243885DERIVEDGuntensperger 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.
PMID: 31049052DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Kleinjung
ENT-Department, University Hospital Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
March 9, 2015
Study Start
March 1, 2015
Primary Completion
August 24, 2017
Study Completion
August 24, 2017
Last Updated
October 31, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share