Effects of Transcranial Static Magnetic Stimulation (tSMS) in the Treatment of Hyperkinetic Symptoms of Huntington's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Reduction of choreic hyperkinesias and akathisia in patients with HD
研究概览
简要总结
Huntington's disease (HD) is a neurodegenerative pathology characterized by choreic hyperkinesias which represent the typical motor symptom and are represented by involuntary, aimless, irregular, recurrent, unpredictable and non-rhythmic movements of the trunk, face and limbs.
Non-invasive brain neuromodulation has been proposed as a possible treatment for involuntary movements in several clinical conditions including HD.
The objective of the study is to evaluate the effect of home treatment with repeated sessions of transcranial static magnetic field stimulation (tSMS) in safely reducing choreic hyperkinesis in HD patients.
详细描述
A two-week course of repetitive magnetic stimulation (rTMS) has been shown to exert persistent clinical beneficial effects, reducing peak drug dyskinesias for up to four weeks after the end of the stimulation period. rTMS has also been reported to have a beneficial effect in HD. In particular, the stimulation showed a significant reduction in involuntary movements in a group of symptomatic patients.
Unlike rTMS, tSMS is attracting considerable interest because it is more manageable and easier to apply. This is a method applicable using a portable ergonomic helmet that shifts the paradigm of non-invasive brain stimulation (NIBS) from a center-based therapeutic model to a home-based one.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HD genetically confirmed (number of CAG triplets ≥36)
- •Presence of chorea movements quantified with a score ≥ 10 on the sum of the scores of the subscale of the Unified Huntington's Disease Rating Scale (UHDRS) for the evaluation of maximum chorea for the facial, oro-bucco-lingual, truncal, four limbs districts
- •Ability to provide written informed consent
- •No changes in drug therapy in the 8 weeks prior to the baseline visit
- •No changes in drug therapy for the entire duration of the study
排除标准
- •Contraindications to exposure to magnetic fields
- •Patients who are pregnant or breastfeeding
- •Presence of significant risk of suicidal behavior
- •Patients who have received an investigational drug in a clinical trial within 30 days of the baseline visit or have planned to use such an investigational drug during the study
研究组 & 干预措施
HD patients undergo real tSMS
Each HD patients undergo tSMS (real) in two sessions per day, each lasting 60 minutes.
干预措施: Portable ergonomic helmet for real tSMS (Device)
HD patients undergo placebo tSMS
Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.
干预措施: portable ergonomic helmet for placebo tSMS (Device)
结局指标
主要结局
Reduction of choreic hyperkinesias and akathisia in patients with HD
时间窗: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation
The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in 30 patients with HD. The Unified Huntington's Disease Rating Scale will be used to assessed maximal chorea in different body districts (face, bucco-oral-lingual, trunk, upper and lower extremity) before and after treatment. Akathisia will be instead determined with the Barnes Akathisia Rating Scale.
次要结局
- Modulation of neuropsychiatric symptoms(The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation)
研究者
Diego Centonze
MD, Principal Investigator
Neuromed IRCCS