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Активно (без набиране) Не е приложимо NCT05830110

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Parkinson's Disease

Спонсор: Synergic Medical Technologies, Inc.

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
Inclusion Criteria: * between the ages 45 and 90 * diagnosis of bilateral, moderate stage idiopathic PD * qualify for EEG procedures Exclusion Criteria: * on dopamine agonist medications and exhibiting compulsive behaviors
Интервенции
Active Vibrotactile Coordinated Reset
DEVICE
Sham vibrotactile coordinated reset
DEVICE
Места на провеждане 1
САЩ (1)
Synergic Medical Technologies
Eugene , Oregon
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
45 Years
Максимална възраст
90 Years
Здрави доброволци
Не
Начална дата
01.03.2023
Крайна дата
01.06.2026
Регистрационен номер
NCT05830110
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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