Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus)
研究概览
简要总结
The objective of the investigators study is to assess conventional repetitive transcranial magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized, double-blind, sham-controlled procedure, with four increasing levels of magnetic "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while controlling its safety and tolerability. By combining various rTMS protocols with a twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of therapeutic management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 75 years old;
- •Adequate medical condition (ASA P1 or P2 in Physical Status Classification System);
- •Disabling tinnitus (STSS > 8/16 or THQ > 50%), with the following characteristics: continuous, subjective, non-pulsatile; unilateral (or bilateral with unilateral predominance), chronic (duration for at least one year), refractory for usual treatments taken for at least six months;
- •Naive regarding TMS;
- •Able to provide informed consent.
排除标准
- •Objective tinnitus or tinnitus with treatable cause;
- •Presence of intracranial or intraocular ferromagnetic materiel or particles (with the exception of dental fillings and MRI-compatible stapedectomy prosthesis);
- •Cardiac pacemaker or other electronic implants (including cochlear implant);
- •Serious heart disease or other unstable major medical condition;
- •Personal history of central nervous system disorder, head injury, stroke or seizures (including childhood febrile seizures);
- •Familial history of epilepsy;
- •Concomitant medication with antidepressants and antipsychotics;
- •Possibility of pregnancy;
- •Known claustrophobia;
- •Others known contraindications to rTMS or brain MRI;
- •Refusal to be informed about the results of anatomical MRI
结局指标
主要结局
Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus)
时间窗: At subject enrollment; daily for 2 weeks before the intervention; before and after each rTMS session, once at the end of each week and at the end of intervention; during follow-up: twice a week for 6 months, and 1 year after the end of intervention
The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months); depending on the protocol, the end of the intervention corresponds to the end of week 1, 4, 5 or 20 (first day of rTMS as reference)
次要结局
- Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events(After the first rTMS session; before and after each following session and at the end of intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Auditory status, evaluated through tonal audiometry (pure-tone average)(At subject enrollment; before the first rTMS session and after the last rTMS session (for all types of protocols), and every five sessions of rTMS (for long protocols))
- Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS)(At subject enrollment; before the first rTMS session, in the middle and at the end of intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Change in handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ)(At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire(At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS)(At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI)(At subject enrollment)
- Change in tinnitus spectrum (loudness and pitch), characterized through psychoacoustical measurements: tinnitometry(At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention)
- Motivation level, assessed through a short self-questionnaire (Likert-type scale)(At the beginning of intervention period (before the first rTMS session) (day 1))
- Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention(At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference))