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临床试验/NCT02978924
NCT02978924已完成不适用

Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Change in maximal time in the upright position without support

研究概览

简要总结

To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore both motor and sensory pathways of the spinal cord leading to functional improvements.

详细描述

Regain of function and improvement of motor skills is a major challenge in motor disorders in which spinal cord functions play a key role. The growing development of non-invasive brain stimulations in the past decade led to significant progress in the understanding of neuronal abnormalities in patients with movement disorders that opens up new vistas for experimental treatments. However, these treatments are currently limited due to their high cost and lack of possibility to use in outpatients. Recently, trans-spinal direct current stimulation (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This may be an excellent alternative to epidural stimulation, the sole technique available up to now to alter spinal functions in an invasive fashion. The overall goal of this study is to assess the potential of tsDCS to restore spinal cord functions in patients with primary orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high disability for patients.

Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS (with the active electrodes over the thoracic level and the reference electrode on the right shoulder) will be delivered to 15 patients with POT. The maximal time in upright position determined by a force platform, the cortical excitability assessed by transcranial magnetic stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent inhibition) and EMG activities of lower extremity muscles will be measured before (PRE), immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and sham tsDCS will be delivered in two different sessions with a washout period of at least 7 days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to modulate both sensory and motor functions in POT and will, in turn, lead to functional improvement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with POT diagnosed since at least 1 year
  • •Normal neurological examination with the exception of POT
  • •Patients with or without treatment for TOP, or with treatment not sufficiently effective
  • •Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme
  • •Signed informed consent

排除标准

  • •Psychiatric or neurological conditions (with the exception of POT)
  • •Presence of potential tsDCS risk factors including an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system, damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
  • •Presence of TMS risk factor including cardiac pacemaker, history of epilepsy, traumatic brain injury with loss of consciousness, intracerebral clips, cochlear or ocular implants
  • •Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study
  • •Patients enrolled in another biomedical research at the time of the study
  • •Participant who does not wish to be informed of any clinically relevant abnormalities (as determined by the investigators) identified during the course of the study
  • •Patient under guardianship or curatorship, or under judicial supervision

研究组 & 干预措施

Cathodal tsDCS

Active Comparator

20 min of active treatment

干预措施: tsDCS (Device)

Sham tsDCS

Sham Comparator

20 min of sham treatment

干预措施: tsDCS (Device)

结局指标

主要结局

Change in maximal time in the upright position without support

时间窗: Before (PRE) and immediately after current offset (POST0)

Force plateform

次要结局

  • Cortical excitability assessed by Transcranial Magnetic Stimulation(Before (PRE), immediately after (POST0) and 30min (POST30) current offset)
  • Quantitative assessment of tremor (EMG)(Before (PRE), immediately after (POST0) and 30min (POST30) current offset)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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