Clinical trial NCT03773926: Neuro-feedback Therapy for Treating Tinnitus
Official title: Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Hearing Loss
Keywords: Tinnitus
Neuro-feedback
Male
Female
Tinnitus Handicap Inventory
Lead sponsor: Zeta Technologies
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Toulouse
First posted: 2018-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
timeFrame: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
Secondary outcomes:
measure: Comparison of initial and final Visual Analog Scale (VAS) distributions
timeFrame: Comparison of initial and final VAS before and after treatment for a Time frame of 5 weeks.
measure: Evolution of Tinnitus Handicap Inventory (THI) and Visual Analog Scales (VAS) on tinnitus intensity and associated disturbance 3 month after the treatment
timeFrame: 3 months after the end of the 5 week treatment
measure: Side effects
timeFrame: The total duration of the study
measure: Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.
timeFrame: Comparison of initial and final BAHIA before and after treatment for a Time frame of 5 weeks.
measure: Correlation of the electrophysiological measurements and the THI/VAS measurements
timeFrame: Over the 5 weeks of treatment
measure: Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value
timeFrame: Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.
Other outcomes:
Locations:
city: Paris
country: France
facility: Audika Research Center
state: Ile De France
city: Toulouse
country: France
facility: Purpan University hospital
state: Languedoc-Roussillon-Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: Marie-Josée FRAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dohrmann 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.
citation: Hartmann 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.
citation: Guillard 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.