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Neuro-feedback Therapy for Treating Tinnitus (TNTA)

Primary Purpose

Tinnitus, Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuro-feedback therapy
Sponsored by
Zeta Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Neuro-feedback, Male, Female, Tinnitus Handicap Inventory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Audika Research CenterRecruiting
  • Purpan University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuro-feedback therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of initial and final Visual Analog Scale (VAS) distributions
The secondary outcome measure denotes the evolution of the intensity of tinnitus and the disturbance associated measured by two scales. First the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). Second, the Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance. The scores are assessed subjectively by the patient when asked.
Evolution of Tinnitus Handicap Inventory (THI) and Visual Analog Scales (VAS) on tinnitus intensity and associated disturbance 3 month after the treatment
Evaluation of maintenance of effects perceived 3 months after the treatment. The THI and the VAS scales are used similarly to the precedent outcome measures. 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. the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). The Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both visual analog scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance.
Side effects
Evaluation of potential side effects during the study. At each session patients will be asked if they want to declare any side effects they believe to be related to the treatment.
Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.
Evaluation of the proportion of daily time that the patient reports experiencing and being disturbed by his tinnitus through 4 questions.
Correlation of the electrophysiological measurements and the THI/VAS measurements
Correlation between the plastic effects induced by therapy on electrophysiological measurements and the assessment of the severity of tinnitus through the THI/VAS.
Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value
Evolution of the precedent quoted measures before and after treatment measured as percentages of the initial value (proportion of evolution of the THI, VAS and BAHIA measurements).

Full Information

First Posted
October 3, 2018
Last Updated
December 11, 2018
Sponsor
Zeta Technologies
Collaborators
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03773926
Brief Title
Neuro-feedback Therapy for Treating Tinnitus
Acronym
TNTA
Official Title
Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Anticipated)
Study Completion Date
January 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeta Technologies
Collaborators
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Hearing Loss
Keywords
Tinnitus, Neuro-feedback, Male, Female, Tinnitus Handicap Inventory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An efficiency multicentric pilot study on a targeted population for development and use of Neuro-feedback therapy for treating tinnitus.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuro-feedback therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuro-feedback therapy
Intervention Description
The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.
Primary Outcome Measure Information:
Title
Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
Description
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.
Time Frame
Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
Secondary Outcome Measure Information:
Title
Comparison of initial and final Visual Analog Scale (VAS) distributions
Description
The secondary outcome measure denotes the evolution of the intensity of tinnitus and the disturbance associated measured by two scales. First the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). Second, the Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance. The scores are assessed subjectively by the patient when asked.
Time Frame
Comparison of initial and final VAS before and after treatment for a Time frame of 5 weeks.
Title
Evolution of Tinnitus Handicap Inventory (THI) and Visual Analog Scales (VAS) on tinnitus intensity and associated disturbance 3 month after the treatment
Description
Evaluation of maintenance of effects perceived 3 months after the treatment. The THI and the VAS scales are used similarly to the precedent outcome measures. 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. the Visual Analog Scale (VAS) for intensity of Tinnitus enables the patient to rate his tinnitus intensity with integers values between 1 to 10 (included). The Visual Analog Scale (VAS) for Tinnitus associated disturbance enables the patient to rate his tinnitus associated diturbance with integers values between 1 to 10 (included). For both visual analog scales, a high value (near 10) indicates a high gravity of the symptom, regarding either its intensity or its associated disturbance, while low values (near 1), indicate lighter impact of the symptom regarding its intensity or its associated disturbance.
Time Frame
3 months after the end of the 5 week treatment
Title
Side effects
Description
Evaluation of potential side effects during the study. At each session patients will be asked if they want to declare any side effects they believe to be related to the treatment.
Time Frame
The total duration of the study
Title
Evolution of pathological attention level (BAHIA) standing for (in french) Biphasique, Acouphène, Hyperacousie, Insensibilité de la face et Autres sensations.
Description
Evaluation of the proportion of daily time that the patient reports experiencing and being disturbed by his tinnitus through 4 questions.
Time Frame
Comparison of initial and final BAHIA before and after treatment for a Time frame of 5 weeks.
Title
Correlation of the electrophysiological measurements and the THI/VAS measurements
Description
Correlation between the plastic effects induced by therapy on electrophysiological measurements and the assessment of the severity of tinnitus through the THI/VAS.
Time Frame
Over the 5 weeks of treatment
Title
Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value
Description
Evolution of the precedent quoted measures before and after treatment measured as percentages of the initial value (proportion of evolution of the THI, VAS and BAHIA measurements).
Time Frame
Comparison of initial and final measurements before and after treatment for a Time frame of 5 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain LONDERO
Phone
05 61 77 21 19
Email
Alain.londero@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud SIMEON
Phone
01 40 19 36 61
Email
r.simeon@ch-bry.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Josée FRAYSSE
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audika Research Center
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROBIN GUILLARD
Phone
0033642480836
Email
r@zetatech.fr
First Name & Middle Initial & Last Name & Degree
THOMAS CERVONI
Phone
0033638895203
Email
t@zetatech.fr
First Name & Middle Initial & Last Name & Degree
ALAIN LONDERO
First Name & Middle Initial & Last Name & Degree
RENAUD SIMEON
Facility Name
Purpan University hospital
City
Toulouse
State/Province
Languedoc-Roussillon-Midi-Pyrénées
ZIP/Postal Code
31300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan SCHMUTZ
Phone
0033634390378
Email
j@zetatech.fr
First Name & Middle Initial & Last Name & Degree
Agnès AGASSE
Phone
00335 61 77 77 70
First Name & Middle Initial & Last Name & Degree
Marie-Josée FRAYSSE

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21592701
Citation
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.
Results Reference
background
PubMed Identifier
17956812
Citation
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.
Results Reference
background
PubMed Identifier
23700271
Citation
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.
Results Reference
background
PubMed Identifier
33637216
Citation
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.
Results Reference
derived
Links:
URL
https://www.hindawi.com/journals/np/2014/436146/
Description
Reduced Variability of Auditory Alpha Activity in Chronic Tinnitus

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Neuro-feedback Therapy for Treating Tinnitus

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