Neuro-feedback Therapy for Treating Tinnitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population

Conditions
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Tinnitus, Hearing Loss

Intervention / Treatment
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* Device: Neuro-feedback therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : 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 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuro-feedback therapy<br>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. | Device: Neuro-feedback therapy<br>* The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Neuro-feedback, Male, Female, Tinnitus Handicap Inventory