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ICCAC-ToNF & Tinnitus (ICCAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895047
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol.

Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness).

Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied.

Based on this multifocal (Insula, dorsal anterior cingulate cortex & auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.


Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Other: tomographic EEG Neurofeedback Training Not Applicable

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Study Type : Interventional
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: dACC,I,AC

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient

Active Comparator: dACC,AC,I

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient

Active Comparator: I,dACC,AC

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient

Active Comparator: I,AC,dACC

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient

Active Comparator: AC,dACC,I

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient

Active Comparator: AC,I,dACC

Within each training session, participants will receive 7 minutes training for each of the three brain areas Insula (I), dorsal anterior cingulate cortex (dACC) & the auditory cortex (AC) resulting in 21Minutes of training for each session. The arm Title describes the order in which participants within this Arm will receive the three trainings. (E.g. dACC,I,AC: each participant in this group receives the training of the dACC first and the AC last.) This sequence order is kept stable during all training sessions.

12 sessions of Neurofeedback Training, 1-2 times per week.

Other: tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver feedback for the patient




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

  2. Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex [ Time Frame: 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. brain structure (volume, surface area) of the three regions of interest as predictor for training success. [ Time Frame: Baseline (measurement before training) ]
    MRI measurement before training



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic tinnitus (>6 months)
  • Age 40 to 80
  • Informed Consent
  • Fluent in German language
  • mentally & physically fit

Exclusion Criteria:

  • ferromagnetic implants
  • cochlear implants
  • average hearing loss over 50 dB
  • claustrophoby
  • addiction to alcohol or drugs
  • intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
  • acute suicidal

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): NCT03895047


Locations
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Switzerland
University Hospital Zurich, Division of Otorhinolaryngology ORL Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Tobias Kleinjung, Prof. Dr.    +41 44 255 58 55    tobias.kleinjung@usz.ch   
Contact: David Talaska, M.Sc.    +41 44 635 22 18    david.talaska@usz.ch   
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03895047    
Other Study ID Numbers: 2018-01035
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases