The Safety of Remote DBS Programming System

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Pilot Study to Investigating Safety of A Remote and Wireless Deep Brain Stimulation Programming System for Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: SceneRay wireless and remote DBS system


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote programming system<br> | Device: SceneRay wireless and remote DBS system<br>* Implement therapeutic programming in patients with network coverage at home<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Unified Parkinson's Disease Rating Scale III&IV |  | Through study completion, an average of 4 months | 
| Deep Brain Stimulation Programming parameter | Contact selection | Through study completion, an average of 4 months | 
| Deep Brain Stimulation Programming parameter | Pulse width | Through study completion, an average of 4 months | 
| Deep Brain Stimulation Programming parameter | Frequency | Through study completion, an average of 4 months | 
| Deep Brain Stimulation Programming parameter | Amplitude | Through study completion, an average of 4 months | 
| Serious Adverse Event |  | Through study completion, an average of 4 months |