The Safety of Remote DBS Programming System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2018-03-01

Brief Summary

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Remote programming has significant advantages over conventional programming methods on some issues. This research will test the safety of SceneRay remote and wireless DBS programming system.

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Detailed Description

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Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the final success of DBS. Optimal programming helps patients achieve maximized control of clinical symptoms and higher life quality. However, there are a number of inadequacies in conventional programming methods. First, the programming probe must come into close contact with the implantable pulse generator (IPG) and test stimulator to complete programming. And during initial postoperative programming, only the parameters of one patient can be ascertained. In addition, the same frequency is typically used in the left and right brain for dual channel IPG. The patient also need to repeatedly travel between their home and the hospital, leading to increased time and expense. Therefore, the investigators developed the SceneRay wireless and remote DBS system to address the outline issues. This system has significant advantages over conventional programming methods on all the issues above. This research will test the safety of this remote and wireless DBS programming system.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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remote programming system

Group Type EXPERIMENTAL

SceneRay wireless and remote DBS system

Intervention Type DEVICE

Implement therapeutic programming in patients with network coverage at home

Interventions

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SceneRay wireless and remote DBS system

Implement therapeutic programming in patients with network coverage at home

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and remote DBS system,
* Age 18-75 years,
* Achieved optimal control of clinical symptoms after coventional programming for 3-12 months,
* Significant difference in motor function when DBS is switched on/off,
* Good compliance and easy to follow-up,

Exclusion Criteria

* No significant improvement or clinical efficacy in symptoms after surgery,
* Severe cognitive impairment due to dementia (Mini-Mental State Examination score: illiteracy \<17, elementary school \<20, junior high school or above \<24) or inability to accurately record in a diary,
* Active psychosis or a history of psychosis,
* Serious heart, liver, or kidney diseases,
* Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases,
* Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,
* Severe alcohol dependence or drug abuse,
* Any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future,
* Participating in other clinical trials,
* Other factors that researchers think may not be suitable for research.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No