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ICCAC-ToNF & Tinnitus (ICCAC)

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ClinicalTrials.gov Identifier: NCT03895047
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date June 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ICCAC-ToNF & Tinnitus
Official Title  ICMJE Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus, Subjective
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
  • 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.

    Intervention: Other: tomographic EEG Neurofeedback Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 7, 2021
Actual Primary Completion Date June 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03895047
Other Study ID Numbers  ICMJE 2018-01035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Zurich
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP