Tinnitus, SubjectiveICCACNCT03895047
ICCAC-ToNF & Tinnitus
A study testing tomographic EEG Neurofeedback Training in people with Tinnitus, Subjective, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- tomographic EEG Neurofeedback Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 7 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tinnitus (>6 months)
- Age 40 to 80
- Informed Consent
- Fluent in German language
- mentally \& physically fit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Otorhinolaryngology ORL
Zurich, Canton of Zurich, 8091
About this study
Official title: Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
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).
Read more
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.
- Conditions
- Tinnitus, Subjective
- Being tested
- tomographic EEG Neurofeedback Training
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomographic EEG Neurofeedback TrainingOther
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 group | Role | What they receive |
|---|---|---|
| dACC,I,AC | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
| dACC,AC,I | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
| I,dACC,AC | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
| I,AC,dACC | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
| AC,dACC,I | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
| AC,I,dACC | Active comparator | 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. Receives: Other: tomographic EEG Neurofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Tinnitus symptoms assessed by questionnaires
Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires
Measured: Time Frame: at 1, 3, 6 month follow up
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
Measured: Time Frame: at 1, 3, 6 month follow up
Secondary outcomes (1)
brain structure (volume, surface area) of the three regions of interest as predictor for training success.
MRI measurement before training
Measured: Baseline (measurement before training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jul 2018
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895047
- Sponsor's protocol ID
- 2018-01035
- Other IDs
- 2018
- Acronym
- ICCAC
- Status last verified
- Oct 2021
- First submitted
- 27 Mar 2019
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
- ClinicalTrials.gov ID
- NCT03895047
- Acronym / sponsor ID
- ICCAC / 2018-01035
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| dACC,I,AC | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
| dACC,AC,I | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
| I,dACC,AC | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
| I,AC,dACC | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
| AC,dACC,I | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
| AC,I,dACC | Active comparator | Other: tomographic EEG Neurofeedback TrainingWithin 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic tinnitus (>6 months)
- Age 40 to 80
- Informed Consent
- Fluent in German language
- mentally \& physically fit
Key exclusion criteria (7 listed)
- ferromagnetic implants
- cochlear implants
- average hearing loss over 50 dB
- claustrophoby
- addiction to alcohol or drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tomographic EEG Neurofeedback TrainingEEG-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 | Other | AC,I,dACC, AC,dACC,I, I,AC,dACC, I,dACC,AC, dACC,AC,I, dACC,I,AC |
Primary outcome
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
1 secondary outcome
brain structure (volume, surface area) of the three regions of interest as predictor for training success.
Time frame: Baseline (measurement before training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomographic EEG Neurofeedback Training in people with Tinnitus, Subjective, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Tinnitus symptoms assessed by questionnaires (time frame: Time Frame: at 1, 3, 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.