Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Neuro-feedback therapy (Device)
结局指标
主要结局
Comparison of initial and final Tinnitus Handicap Inventory (THI) distributions
时间窗: Comparison of initial and final THI before and after treatment for a Time frame of 5 weeks.
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.
次要结局
- Side effects(The total duration of the study)
- Evolution of the THI, BAHIA, and VAS scores, expressed as a percentage of the initial value(Comparison of initial and final measurements 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)
- 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)
- 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.)