NCT03773926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

October 3, 2018

Last Update Submit

December 11, 2018

Conditions

TinnitusHearing Loss

Keywords

TinnitusNeuro-feedbackMaleFemaleTinnitus Handicap Inventory

Outcome Measures

Primary Outcomes (1)

  • Comparison 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.

    Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.

Secondary Outcomes (6)

  • Comparison of initial and final Visual Analog Scale (VAS) distributions

    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

    3 months after the end of the 5 week treatment

  • Side effects

    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.

    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

    Over the 5 weeks of treatment

  • +1 more secondary outcomes

Study Arms (1)

Neuro-feedback therapy

EXPERIMENTAL

EEG headset is placed on the patients head and the electrodes record the brain activity from F3, F4, FC1 and FC2 (on the 10-10 international localization system of EEG electrodes) and generate feedback. Each session is composed of 6 blocks of 3 minutes in which the patient is incited to practice a specific cognitive strategy. During the 4 first session, 8 strategies are explored. Then through the therapy, the best cognitive strategies are gradually selected through an automatized process taking in account objective performances and subjective feedback.

Device: Neuro-feedback therapy

Interventions

Neuro-feedback therapyDEVICE

The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.

Neuro-feedback therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Purpan University hospital

Toulouse, Occitanie, 31300, France

RECRUITING

Audika Research Center

Paris, Île-de-France Region, 75005, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21592701BACKGROUND

  • 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.

    PMID: 17956812BACKGROUND

  • 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.

    PMID: 23700271BACKGROUND

  • 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.

    PMID: 33637216DERIVED

MeSH Terms

Conditions

TinnitusHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Josée FRAYSSE

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain LONDERO

CONTACT

05 61 77 21 19Alain.londero@aphp.fr

Renaud SIMEON

CONTACT

01 40 19 36 61r.simeon@ch-bry.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

December 12, 2018

Study Start

May 28, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)