Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- Zeta Technologies
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
- Last Updated
- 7 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Side effects(The total duration of the study)
- Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value(Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.)
- Correlation of the electrophysiological measurements and the THI/VAS measurements(Over the 5 weeks of treatment)
- Comparison of initial and final Visual Analog Scale (VAS) distributions(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(3 months after the end of the 5 week treatment)
- Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.(Comparison of initial and final BAHIA before and after treatment for a Time frame of 5 weeks.)