Status:
UNKNOWN
Neuro-feedback Therapy for Treating Tinnitus
Lead Sponsor:
Zeta Technologies
Collaborating Sponsors:
University Hospital, Toulouse
Conditions:
Tinnitus
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
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 res...
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 p...
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 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
Exclusion
Key Trial Info
Start Date :
May 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03773926
Start Date
May 28 2018
End Date
January 15 2019
Last Update
December 12 2018
Active Locations (2)
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1
Purpan University hospital
Toulouse, Occitanie, France, 31300
2
Audika Research Center
Paris, Île-de-France Region, France, 75005