The Safety of Remote DBS Programming System

Not Applicable

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Device: SceneRay wireless and remote DBS system

• Registration Number: NCT03267550
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Status Verified: 2018-03
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
remote programming system	SceneRay wireless and remote DBS system	-

Primary Outcome Measures

Name	Time	Method
The Unified Parkinson's Disease Rating Scale III&IV	Through study completion, an average of 4 months
Deep Brain Stimulation Programming parameter	Through study completion, an average of 4 months	Amplitude
Serious Adverse Event	Through study completion, an average of 4 months

Trial Locations

Locations (1)

Shanghai Ruijin Hospital Functional Neurosurgery; 🇨🇳 Shanghai, Shanghai, China