TinnitusTNTANCT03773926
Neuro-feedback Therapy for Treating Tinnitus
A study testing Neuro-feedback therapy in people with Tinnitus and Hearing Loss, run by Zeta Technologies at 2 sites in France.
Trial summary
Neuro-feedback for treating tinnitus seem to be a promising approach to help people suffering from chronic tinnitus. The past studies on this approach suffered interindividual variability in their results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Hearing Loss
- What is being tested?
- Neuro-feedback therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 28 May 2018to 15 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Social security affiliation
- Permanent, non-fluctuation, high pitch, bilateral or assimilated, tinnitus
- Mean value of the VAS at least at 6 between the intensity and the disturbance criteria at the recruitment interview.
- THI score superior or equal to 40 at the recruitment interview
- Written consent to the protocol
Show all 10Show fewer
- Associated hearing-loss characterized by :
- mean value of the hearing threshold loss for the 250, 500 and 1000 Hz thresholds strictly under 25 dB (deciBel).
- at least one hearing threshold among the 2000, 4000, 6000 and 8000 Hz with at least 30 dB of hearing loss.
- mean value of the hearing threshold loss for the 2000, 4000, 6000 and 8000 Hz thresholds strictly under 70 dB.
Who cannot join
- Subjects under legal protection (guardianship, trusteeship or judicial protection)
- Notable cognitive disability impeding to understanding or performing the cognitive tasks
- Meniere's disease, chronic or serous otitis, acoustic neuroma
- Pulsatile tinnitus, somatosensorial tinnitus
- Epilepsy
- No antidepressant or anti-epileptic drug treatment
Show all 10Show fewer
- DET (DETresse) questionnaire (measure of tinnitus associated distress) above or equal to 40
- Use of a sound generator during the therapy
- Pregnancy or breastfeeding
- Inability to wear the electrodes headset of the neuro-feedback device
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Audika Research Center
Paris, Île-de-France Region, 75005
ROBIN GUILLARD, 0033642480836, r@zetatech.fr
THOMAS CERVONI, 0033638895203, t@zetatech.fr
- Recruiting
Purpan University hospital
Toulouse, Occitanie, 31300
Jonathan SCHMUTZ, 0033634390378, j@zetatech.fr
Agnès AGASSE, 00335 61 77 77 70
About this study
Official title: Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
Neuro-feedback for treating tinnitus seem to be a promising approach to help people suffering from chronic tinnitus. The past studies on this approach suffered interindividual variability in their results. The investigators' current hypothesis is that the variability of the results is the consequences of two possible flaws: lack of appropriate patient selection and lack of support of the patient during the therapy. This study is aimed at testing these hypotheses.
Read the detailed description
Many individuals with tinnitus have abnormal oscillatory brain activity in their temporal areas (Weisz et al. (2005), Schlee et al. (2014)). Led by this finding, attempts to normalize such localized pathological activity by neuro-feedback techniques have been tested (Dohrmann et al. (2007), Gütenspenger et al. (2017)). These attempts highlighted interindividual variability that can be explained by lack of selection of the patient population and lack of guidance through the therapy. The present study is aimed at addressing these issues by choosing more selectively a patient subpopulation (tinnitus associated with moderate hearing loss) and by implementing a guidance interface during the treatment.
The therapy will consist of 10 neuro-feedback training sessions of 29 minutes over 5 weeks. Each session will be composed of 6 blocks of 3 min in which the patient will be incited to practise a specific cognitive strategy (mental exercise such as "think to a music you like") and resting state measurements.
Each patient who has been recruited to fit our inclusion and non-inclusion criteria will first go through a clinical assessment of his initial judgment criteria metrics. Then subjects will go through the 5-week training and then will be evaluated on the same criteria just after the end of the therapy and at 3 months after the end of it.
- Conditions
- Tinnitus, Hearing Loss
- Being tested
- Neuro-feedback therapy
- Keywords
- Tinnitus, Neuro-feedback, Male, Female, Tinnitus Handicap Inventory
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-feedback therapyDevice
The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-feedback therapy | Experimental | EEG headset is placed on the patients head and the electrodes record the brain activity from F3, F4, FC1 and FC2 (on the 10-10 international localization system of EEG electrodes) and generate feedback.
Each session is composed of 6 blocks of 3 minutes in which the patient is incited to practice a specific cognitive strategy. During the 4 first session, 8 strategies are explored. Then through the therapy, the best cognitive strategies are gradually selected through an automatized process taking in account objective performances and subjective feedback. Receives: Device: Neuro-feedback therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
This primary outcome measure denotes the evolution of the deterioration of the quality of life of patients due to tinnitus. THI is a questionnaire composed of 25 questions each with 3 response options converting in 0, 2, and 4 points scoring, making it a scale from 0 to 100 points.
Measured: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
Secondary outcomes (6)
Comparison of initial and final Visual Analog Scale (VAS) distributions
The secondary outcome measure denotes the evolution of the intensity of tinnitus and the disturbance associated measured by two scales. First the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). Second, the Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance. The scores are assessed subjectively by the patient when asked.
Measured: Comparison of initial and final VAS before and after treatment for a Time frame of 5 weeks.
Evolution of Tinnitus Handicap Inventory (THI) and Visual Analog Scales (VAS) on tinnitus intensity and associated disturbance 3 month after the treatment
Evaluation of maintenance of effects perceived 3 months after the treatment. The THI and the VAS scales are used similarly to the precedent outcome measures. THI is a questionnaire composed of 25 questions each with 3 response options converting in 0, 2, and 4 points scoring, making it a scale from 0 to 100 points. the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). The Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both visual analog scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance.
Measured: 3 months after the end of the 5 week treatment
Side effects
Evaluation of potential side effects during the study. At each session patients will be asked if they want to declare any side effects they believe to be related to the treatment.
Measured: The total duration of the study
Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.
Evaluation of the proportion of daily time that the patient reports experiencing and being disturbed by his tinnitus through 4 questions.
Measured: Comparison of initial and final BAHIA before and after treatment for a Time frame of 5 weeks.
Correlation of the electrophysiological measurements and the THI/VAS measurements
Correlation between the plastic effects induced by therapy on electrophysiological measurements and the assessment of the severity of tinnitus through the THI/VAS.
Measured: Over the 5 weeks of treatment
Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value
Evolution of the precedent quoted measures before and after treatment measured as percentages of the initial value (proportion of evolution of the THI, VAS and BAHIA measurements).
Measured: Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start28 May 2018
- Primary completion15 Jan 2019 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeta Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Toulouse
- Responsible party
- Sponsor
- Investigators
- Marie-Josée FRAYSSE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773926
- Sponsor's protocol ID
- 2018-A00604-51
- Acronym
- TNTA
- Status last verified
- Dec 2018
- First submitted
- 3 Oct 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17.
PubMed 21592701Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. doi: 10.1016/S0079-6123(07)66046-4.
PubMed 17956812Hartmann T, Lorenz I, Muller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23.
PubMed 23700271Guillard R, Fraysse MJ, Simeon R, Cervoni T, Schmutz J, Piedfort B, Ferat V, Congedo M, Londero A. A portable neurofeedback device for treating chronic subjective tinnitus: Feasibility and results of a pilot study. Prog Brain Res. 2021;260:167-185. doi: 10.1016/bs.pbr.2020.08.001. Epub 2020 Oct 14.
PubMed 33637216
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
- ClinicalTrials.gov ID
- NCT03773926
- Acronym / sponsor ID
- TNTA / 2018-A00604-51
- Conditions
- Tinnitus, Hearing Loss
- Keywords
- Tinnitus, Neuro-feedback, Male, Female, Tinnitus Handicap Inventory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zeta TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Toulouse
- Study start
- 28 May 2018 (actual)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 12 Dec 2018 (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.
Neuro-feedback for treating tinnitus seem to be a promising approach to help people suffering from chronic tinnitus. The past studies on this approach suffered interindividual variability in their results. The investigators' current hypothesis is that the variability of the results is the consequences of two possible flaws: lack of appropriate patient selection and lack of support of the patient during the therapy. This study is aimed at testing these hypotheses.
Detailed description
Many individuals with tinnitus have abnormal oscillatory brain activity in their temporal areas (Weisz et al. (2005), Schlee et al. (2014)). Led by this finding, attempts to normalize such localized pathological activity by neuro-feedback techniques have been tested (Dohrmann et al. (2007), Gütenspenger et al. (2017)). These attempts highlighted interindividual variability that can be explained by lack of selection of the patient population and lack of guidance through the therapy. The present study is aimed at addressing these issues by choosing more selectively a patient subpopulation (tinnitus associated with moderate hearing loss) and by implementing a guidance interface during the treatment.
The therapy will consist of 10 neuro-feedback training sessions of 29 minutes over 5 weeks. Each session will be composed of 6 blocks of 3 min in which the patient will be incited to practise a specific cognitive strategy (mental exercise such as "think to a music you like") and resting state measurements.
Each patient who has been recruited to fit our inclusion and non-inclusion criteria will first go through a clinical assessment of his initial judgment criteria metrics. Then subjects will go through the 5-week training and then will be evaluated on the same criteria just after the end of the therapy and at 3 months after the end of it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
| Arm | Type | Receives |
|---|---|---|
| Neuro-feedback therapy | Experimental | Device: Neuro-feedback therapyEEG headset is placed on the patients head and the electrodes record the brain activity from F3, F4, FC1 and FC2 (on the 10-10 international localization system of EEG electrodes) and generate feedback. Each session is composed of 6 blocks of 3 minutes in which the patient is incited to practice a specific cognitive strategy. During the 4 first session, 8 strategies are explored. Then through the therapy, the best cognitive strategies are gradually selected through an automatized process taking in account objective performances and subjective feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18
- Social security affiliation
- Permanent, non-fluctuation, high pitch, bilateral or assimilated, tinnitus
- Mean value of the VAS at least at 6 between the intensity and the disturbance criteria at the recruitment interview.
- THI score superior or equal to 40 at the recruitment interview
Key exclusion criteria (10 listed)
- Subjects under legal protection (guardianship, trusteeship or judicial protection)
- Notable cognitive disability impeding to understanding or performing the cognitive tasks
- Meniere's disease, chronic or serous otitis, acoustic neuroma
- Pulsatile tinnitus, somatosensorial tinnitus
- Epilepsy
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 |
|---|---|---|
| Neuro-feedback therapyThe therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks. | Device | Neuro-feedback therapy |
Primary outcome
Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
Time frame: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
This primary outcome measure denotes the evolution of the deterioration of the quality of life of patients due to tinnitus. THI is a questionnaire composed of 25 questions each with 3 response options converting in 0, 2, and 4 points scoring, making it a scale from 0 to 100 points.
6 secondary outcomes
Comparison of initial and final Visual Analog Scale (VAS) distributions
Time frame: Comparison of initial and final VAS before and after treatment for a Time frame of 5 weeks.
Evolution of Tinnitus Handicap Inventory (THI) and Visual Analog Scales (VAS) on tinnitus intensity and associated disturbance 3 month after the treatment
Time frame: 3 months after the end of the 5 week treatment
Side effects
Time frame: The total duration of the study
Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.
Time frame: Comparison of initial and final BAHIA before and after treatment for a Time frame of 5 weeks.
Correlation of the electrophysiological measurements and the THI/VAS measurements
Time frame: Over the 5 weeks of treatment
Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value
Time frame: Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 21592701Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17.
- Background: PubMed 17956812Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. doi: 10.1016/S0079-6123(07)66046-4.
- Background: PubMed 23700271Hartmann T, Lorenz I, Muller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23.
- Derived from this study: PubMed 33637216Guillard R, Fraysse MJ, Simeon R, Cervoni T, Schmutz J, Piedfort B, Ferat V, Congedo M, Londero A. A portable neurofeedback device for treating chronic subjective tinnitus: Feasibility and results of a pilot study. Prog Brain Res. 2021;260:167-185. doi: 10.1016/bs.pbr.2020.08.001. Epub 2020 Oct 14.
- Individual participant dataSharing planned: No
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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.
Marie-Josée FRAYSSE principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-feedback therapy in people with Tinnitus and Hearing Loss, run by Zeta Technologies at 2 sites in France.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain LONDERO (05 61 77 21 19, Alain.londero@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions (time frame: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773926, which also lists 4 linked publications.
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 12 Dec 2018.