NCT06834269进行中（未招募）不适用
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
Campus Bio-Medico University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月2日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- NfL reduction
研究概览
简要总结
The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:
- levels of NF-L and other potential innovative biomarkers,
- clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).
Moreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.
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
- •diagnosis of possible, probable or definite 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 at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 > 4)
- •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)
- •unable to perform spirometry due to severe bulbar involvement
- •contraindications to magnetic fields exposure
- •pregnancy or breastfeeding
- •history of epilepsy or seizures
- •use 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
pwALS
Experimental
All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each.
干预措施: Transcranial magnetic stimulation (tSMS) (Device)
结局指标
主要结局
NfL reduction
时间窗: 12 months
The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment
次要结局
- Effect on motor evoked potentials (MEP) size(12 months)
- Monthly Progression Rate (MPR)(15 months)
- New Potential Theranostic Biomarkers Assay(12 months)
- Effect on resting motor threshold (RMT) and active motor threshold (AMT)(12 months)
研究者
Di Lazzaro Vincenzo
Full Professor of Neurology
Campus Bio-Medico University
研究点 (3)
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