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ICCAC-ToNF & Tinnitus (ICCAC)

Primary Purpose

Tinnitus, Subjective

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

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Division of Otorhinolaryngology ORL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

dACC,I,AC

dACC,AC,I

I,dACC,AC

I,AC,dACC

AC,dACC,I

AC,I,dACC

Arm Description

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.

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.

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.

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.

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.

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.

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
Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods

Secondary Outcome Measures

brain structure (volume, surface area) of the three regions of interest as predictor for training success.
MRI measurement before training

Full Information

First Posted
March 27, 2019
Last Updated
October 12, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03895047
Brief Title
ICCAC-ToNF & Tinnitus
Acronym
ICCAC
Official Title
Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
dACC,I,AC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dACC,AC,I
Arm Type
Active Comparator
Arm Description
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.
Arm Title
I,dACC,AC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
I,AC,dACC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AC,dACC,I
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AC,I,dACC
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
tomographic EEG Neurofeedback Training
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, the insula and the anterior cingulate cortex and deliver 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
Time Frame
Time Frame: at 1, 3, 6 month follow up
Title
Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
Description
EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods
Time Frame
Time Frame: at 1, 3, 6 month follow up
Secondary Outcome Measure Information:
Title
brain structure (volume, surface area) of the three regions of interest as predictor for training success.
Description
MRI measurement before training
Time Frame
Baseline (measurement before training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
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

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ICCAC-ToNF & Tinnitus

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