Status:
WITHDRAWN
The Safety of Remote DBS Programming System
Lead Sponsor:
Ruijin Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03267550
Start Date
August 8 2017
End Date
March 1 2018
Last Update
March 26 2018
Active Locations (1)
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1
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, China, 200025