Neuro-feedback Therapy for Treating Tinnitus

Last updated: December 11, 2018
Sponsor: Zeta Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Deafness

Hearing Loss

Treatment

N/A

Clinical Study ID

NCT03773926
2018-A00604-51
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 criteriaat 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 thresholdsstrictly under 25 dB (deciBel).

  • at least one hearing threshold among the 2000, 4000, 6000 and 8000 Hz with at least 30dB of hearing loss.

  • mean value of the hearing threshold loss for the 2000, 4000, 6000 and 8000 Hzthresholds strictly under 70 dB.

Exclusion

Exclusion Criteria:

  • Subjects under legal protection (guardianship, trusteeship or judicial protection)

  • Notable cognitive disability impeding to understanding or performing the cognitivetasks

  • 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 equalto 40

  • Use of a sound generator during the therapy

  • Pregnancy or breastfeeding

  • Inability to wear the electrodes headset of the neuro-feedback device

Study Design

Total Participants: 30
Study Start date:
May 28, 2018
Estimated Completion Date:
January 15, 2019

Study 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.

Connect with a study center

  • Audika Research Center

    Paris, Ile De France 75005
    France

    Active - Recruiting

  • Purpan University hospital

    Toulouse, Languedoc-Roussillon-Midi-Pyrénées 31300
    France

    Active - Recruiting

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