Informations générales (source: ClinicalTrials.gov)
Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population (TNTA)
Interventional
N/A
Zeta Technologies (Voir sur ClinicalTrials)
mai 2018
janvier 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Purpan University hospital - 31300 - Toulouse - Languedoc-Roussillon-Midi-Pyrénées - France | Jonathan SCHMUTZ | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Audika Research Center - 75005 - Paris - Ile De France - France | ROBIN GUILLARD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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