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Neuro-feedback Therapy for Treating Tinnitus

NCT ID: NCT03773926

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2019-01-15

Brief Summary

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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

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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.

Conditions

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Tinnitus Hearing Loss

Keywords

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Tinnitus Neuro-feedback Male Female Tinnitus Handicap Inventory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neuro-feedback therapy

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.

Group Type EXPERIMENTAL

Neuro-feedback therapy

Intervention Type DEVICE

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

Interventions

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Neuro-feedback therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role collaborator

Zeta Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Josée FRAYSSE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Purpan University hospital

Toulouse, Occitanie, France

Site Status RECRUITING

Audika Research Center

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alain LONDERO

Role: CONTACT

Phone: 05 61 77 21 19

Email: [email protected]

Renaud SIMEON

Role: CONTACT

Phone: 01 40 19 36 61

Email: [email protected]

Facility Contacts

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Jonathan SCHMUTZ

Role: primary

Agnès AGASSE

Role: backup

ROBIN GUILLARD

Role: primary

THOMAS CERVONI

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21592701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17956812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23700271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33637216 (View on PubMed)

Other Identifiers

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2018-A00604-51

Identifier Type: -

Identifier Source: org_study_id