跳至主要内容
临床试验/NCT05830110
NCT05830110进行中(未招募)不适用

Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease

Synergic Medical Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)

研究概览

简要总结

The purpose of the present research is to examine the effectiveness of a non-invasive, vibrotactile stimulation protocol, known as coordinated reset (CR), for the alleviation of motor symptoms in patients with Parkinson's disease (PD). PD patients exhibit rigidity, slowness (bradykinesia) and poverty (akinesia) of movement as well as other symptoms. Treatment for PD is either pharmacological (first line) or invasive deep brain stimulation. The non-invasive, vibrotactile stimulation approach uses a novel stimulation pattern to disrupt the pathophysiological mechanism that is responsible for PD symptoms and thus restore motor function.

详细描述

Up to thirty adults with bilateral, moderate stage idiopathic PD will be enrolled in this longitudinal study. Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals. This longitudinal protocol will be open-ended to enable continued treatment to those interested / motivated.

Study treatment will consist of daily, four-hour vibrotactile Coordinated Reset (vCR) stimulation sessions on a continual basis. All daily vCR stimulation sessions will occur at the participant's home (ON-medication) and can be broken up into two, two-hour blocks (with no more than 12 hours between stimulation blocks) to be less cumbersome and better integrate into the participant's daily life. Daily home-based treatment will be unsupervised, though timely support is guaranteed by Synergic Medical Technologies (SMT) support staff when needed (e.g., when usability or IT issues arise). Daily stimulation / device usage will be automatically logged by the device and continuously monitored by SMT staff, meanwhile participants will keep a med diary so we can monitor their med usage (and how it relates to extended exposure) over time. Participants will be able to transition to an as-needed basis with treatment after four months and once they are familiar with the treatment and their body's response to it, to better alleviate PD symptoms.

研究设计

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

入排标准

年龄范围
45 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages 45 and 90
  • diagnosis of bilateral, moderate stage idiopathic PD
  • qualify for EEG procedures

排除标准

  • on dopamine agonist medications and exhibiting compulsive behaviors

研究组 & 干预措施

Sham vibrotactile coordinated reset

Sham Comparator

mechanical vibrotactile stimulation to the fingers in a defined pattern

干预措施: Sham vibrotactile coordinated reset (Device)

Active vibrotactile coordinated reset

Active Comparator

mechanical vibrotactile stimulation to the fingers in a defined pattern

干预措施: Active Vibrotactile Coordinated Reset (Device)

结局指标

主要结局

Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)

时间窗: baseline, 2 months, 4 months

Change in MDS-UPDRS score using Part 3 of the scale.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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