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

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tomographic Neurofeedback
Non Tomographic Neurofeedback
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective focused on measuring Adult, Aged, Alpha Rhythm, Auditory Cortex, Chronic, Electroencephalography, Female, Humans, Male, Neurofeedback, Prospective Studies, Questionnaires, Tinnitus, Treatment Outcome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Division of Otorhinolaryngology ORL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tomographic Neurofeedback (TONF)

Non Tomographic Neurofeedback (NTE)

Arm Description

15x Neurofeedback Trainings, 1-2 times per week

15x Neurofeedback Trainings, 1-2 times per week

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.

Full Information

First Posted
February 18, 2015
Last Updated
October 30, 2017
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02383147
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
Keywords
Adult, Aged, Alpha Rhythm, Auditory Cortex, Chronic, Electroencephalography, Female, Humans, Male, Neurofeedback, Prospective Studies, Questionnaires, Tinnitus, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tomographic Neurofeedback (TONF)
Arm Type
Experimental
Arm Description
15x Neurofeedback Trainings, 1-2 times per week
Arm Title
Non Tomographic Neurofeedback (NTE)
Arm Type
Active Comparator
Arm Description
15x Neurofeedback Trainings, 1-2 times per week
Intervention Type
Device
Intervention Name(s)
Tomographic Neurofeedback
Intervention Description
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
Intervention Name(s)
Non Tomographic Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Tinnitus symptoms assessed by questionnaires
Description
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.
Time Frame
at 1, 3, 6 month follow up
Title
Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex
Description
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
Time Frame
at 1, 3, 6 month follow up
Secondary Outcome Measure Information:
Title
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.
Description
Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.
Time Frame
at 1, 3, 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kleinjung
Organizational Affiliation
ENT-Department, University Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Otorhinolaryngology ORL
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17956812
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.
Results Reference
background
PubMed Identifier
21592701
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.
Results Reference
background
PubMed Identifier
23700271
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.
Results Reference
background
PubMed Identifier
34243885
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.
Results Reference
derived
PubMed Identifier
31049052
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.
Results Reference
derived

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

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