Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Disease progression
研究概览
简要总结
This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability.
To this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.
Clinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •age between 18 and 75 years
- •diagnosis of ALS according to revised El Escorial criteria and Awaji-Shima criteria
- •disease duration < 24 months
- •ALSFRS-R > 30 at the recruitment
- •ALSFRS-R decline > 1 in the at least 3-months period before the intervention
- •normal respiratory functionality (FVC > 80% and ALSFRS-R items 10,11,12 > 4) at the recruitment
- •treatment with riluzole 50 mg x 2/die
排除标准
- •inclusion in other clinical trials
- •presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
- •contraindications to magnetic fields exposure
- •pregnancy or breast-feeding
- •history of epilepsy or seizures
- •assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
- •cognitive impairment
- •lack of informed consent
研究组 & 干预措施
real tSMS
tSMS will be delivered by a magnet applied to M1, bilaterally (120 min daily, for 6 months). Magnet will be kept in position by a plastic helmet.
干预措施: tSMS (Device)
sham tSMS
A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.
干预措施: sham tSMS (Device)
结局指标
主要结局
Disease progression
时间窗: 9 months
Comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment and the period of six months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.
次要结局
- Safety and tolerability(6 months)
- Compliance(6 months)
- Effect on motor evoked potentials (MEP) size(6 months)
- Effect on resting motor threshold (RMT) and active motor threshold (AMT)(6 months)
研究者
Di Lazzaro Vincenzo
Full Professor of Neurology
Campus Bio-Medico University