Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Assessment of the Effectiveness of Two Months of Use of the Remedee Endorphin Band Medical Device in Improving Motor Disorders in Patients With Parkinson's Disease
研究概览
简要总结
Idiopathic Parkinson's disease is a common neurodegenerative disease, with a prevalence of around 2% in people over 65 years of age in France.
This pathology affects the dopaminergic pathway but also other systems: cholinergic, noradrenergic and serotoninergic.
The symptoms of Parkinson's disease are motor but also non-motor with sleep, smell, cognitive, psychiatric, digestive, urinary, dysautonomic, painful disorders. The discomfort can be such that invasive and expensive solutions have been developed. Invasive or expensive techniques (deep brain stimulation, lesional microsurgery by gamma knife or ultrasound, duodopa or apokinon pumps) brought significant benefits to patients. Opportunities for clinical improvement using less expensive and lighter devices should be sought.
The Remedee endorphin band device is a device that emits millimeter-band electromagnetic waves on the wrist. The device stimulates subcutaneous nerve endings and activates a physiological response leading to the release of endorphins in the brain. Endorphins are involved in several physiological processes, including pain control.
Mu-opioid receptor (MOR) agonists do not only relieve pain, but have effects related to mesolimbic dopaminergic pathways. Indeed, the opioid and dopaminergic systems are closely linked at the cellular level. Endorphins, through inhibition of the release of the neurotransmitter GABA upon binding to the μ receptor, are also linked to an increase in dopamine.
详细描述
Intervention 1 Name : VERUM
Description :
Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months.
Intervention 2 Name : SHAM
Description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
ratio 1 :1 in each centre on an online randomization module
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
- •Patient over 18 years old
- •Follow-up for Parkinson's disease for more than 5 years
- •Treatment stable for at least 3 months
- •Having retained sufficient autonomy to allow participation in the study
- •Hoehn and Yahr score in ON DOPA <4
排除标准
- •Genetic forms of the disease
- •EVA> 7 over the previous week
- •Moderate to severe cognitive impairment
- •Pathology or condition (other than Parkinson's disease) that can generate motor disorders
- •Allergy to metals and / or silicone
- •Dermatological pathology on the wrists
- •Metal object at one of the wrists (implanted metal material, piercing)
- •Presence of a tattoo on one of the wrists
- •Wrist circumference <14.5 cm or> 21 cm i.e. wrist incompatible with the MD template
- •Inability of the patient to put on and / or wear the template of the medical device
- •Pregnant or breastfeeding woman
结局指标
主要结局
Assessment of the Effectiveness of Two Months of Use of the Remedee Endorphin Band Medical Device in Improving Motor Disorders in Patients With Parkinson's Disease
时间窗: two months after inclusion
Decrease of 3.25 points or more in the Movement Disorder Society Unified Parkinson Disease Rating Scale III from inclusion. The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation) will be performed under ON Dopa conditions and blinded from the randomization arm. The MDS-UPDRS III varies from 0 to199, a higher score meaning a worse outcome.
次要结局
未报告次要终点
