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

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ClinicalTrials.gov Identifier: NCT02383147
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Device: Tomographic Neurofeedback Device: Non Tomographic Neurofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus
Study Start Date : March 2015
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Tomographic Neurofeedback (TONF)
15x Neurofeedback Trainings, 1-2 times per week
Device: 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

Active Comparator: Non Tomographic Neurofeedback (NTE)
15x Neurofeedback Trainings, 1-2 times per week
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.




Primary Outcome Measures :
  1. Change from Baseline in Tinnitus symptoms assessed by questionnaires [ Time Frame: at 1, 3, 6 month follow up ]
    Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life.

  2. Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex [ Time Frame: at 1, 3, 6 month follow up ]
    EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods


Secondary Outcome Measures :
  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. [ Time Frame: at 1, 3, 6 month follow up ]
    Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383147


Locations
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Switzerland
University Hospital Zurich, Division of Otorhinolaryngology ORL
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Tobias Kleinjung ENT-Department, University Hospital Zurich

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02383147     History of Changes
Other Study ID Numbers: USZ-ORL-KT-001
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Zurich:
Adult
Aged
Alpha Rhythm
Auditory Cortex
Chronic
Electroencephalography
Female
Humans
Male
Neurofeedback
Prospective Studies
Questionnaires
Tinnitus
Treatment Outcome

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms