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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.
Purpan University hospital
Toulouse, Occitanie, France
RECRUITINGAudika Research Center
Paris, Île-de-France Region, France
RECRUITINGComparison 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.
Time frame: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
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.
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
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.
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Time frame: 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.
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.
Evaluation of the proportion of daily time that the patient reports experiencing and being disturbed by his tinnitus through 4 questions.
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
Correlation between the plastic effects induced by therapy on electrophysiological measurements and the assessment of the severity of tinnitus through the THI/VAS.
Time frame: 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).
Time frame: Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.