The Efficacy of dTMS Among Patient Who Suffer From Tinnitus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Brainsway
- 试验地点
- 1
- 主要终点
- TQ - Tinnitus questionnaire
研究概览
简要总结
The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus
详细描述
Stages of the study:
A. Patient recruitment stage: hearing tests battery including: otoscopy, tympanometry, pure-tone audiometry - 0 to 20 dB HL; 21 to 60 dB HL and more than 60 dB HL, tinnitus matching, TQ and VAS.
B. Patients will be assign to one of two study groups, Deep TMS over the left auditory cortex and Sham. .
C. TMS Acute treatment phase:
TMS treatment will be administer for two weeks: 5 days a week for half an hour. Before each TMS treatment session, patients will undergo training exercises designed to stimulate the neural network associated with attention processes Monitoring for evaluation of treatment efficacy and side effects will be perform on a daily basis. . The overall time of each session is estimate to be 1 hour.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 20-
- •Self-report of tinnitus in one or both ears, persisting for over a year, with no other hearing impairment.
- •Mild/moderate/severe tinnitus. Severity of tinnitus will be diagnosed using the TQ (Goebel & Hiller) / the THI (Newman & Jacobson).
- •Unresponsive to standard tinnitus medication.
- •Normal results on pure tone audiometry testing (threshold ≤ 25 dB hearing level in all frequencies from 250 to 8000 Hz).
- •Normal middle ear status was demonstrated by tympanometry, stapedius reflex tests, and otoscopy.
- •Normal results on neurological and physiological examinations.
- •Gave their oral and written consent to participate in the trial.
排除标准
- •A DSM-IV Axis-I psychiatric disorder.
- •Use of medication that may be a risk factor for seizures, such as:
- •antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
- •History of intolerance to TMS.
- •Diagnosis of a severe personality disorder according to the DSM-IV.
- •Current suicidal ideation.
- •Uncontrolled hypertension.
- •History of epilepsy, seizure, or heat convulsion.
- •History of epilepsy or seizure in first degree relatives.
- •History of head injury or stroke.
- •History of any metallic particles in the head (except dental fillings).
- •History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemakers, cochlear implants, use of neurostimulators, or any medical pumps.
- •History of drug or alcohol abuse.
- •Inability to communicate adequately with examiner.
- •Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
- •Inability to sign a consent form.
- •Pregnancy or inadequate birth control.
- •Severe hearing impairment.
研究组 & 干预措施
1Hz dTMS Real
This group will receive dTMS real treatment of 1Hz
干预措施: Deep Transcranial Magnetic Stimulation (Device)
1HZ dTMS SHAM
This group will receive 1HZ dTMS SHAM treatment
干预措施: Deep Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
TQ - Tinnitus questionnaire
时间窗: 90 days after the last treatment session
次要结局
- VAS (100 - worst possible tinnitus related discomfort; 0 - wellness)(baseline, week 1: day 1-5, and week 2: day 1-5)