Study Stopped
The sponsor terminated industrial support
The Safety of Remote DBS Programming System
A Pilot Study to Investigating Safety of A Remote and Wireless Deep Brain Stimulation Programming System for Parkinson's Disease
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2017
CompletedFirst Submitted
Initial submission to the registry
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 26, 2018
March 1, 2018
7 months
August 23, 2017
March 22, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
remote programming system
EXPERIMENTALInterventions
Implement therapeutic programming in patients with network coverage at home
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, 200025, China
Related Publications (5)
Li D, Zhang C, Gault J, Wang W, Liu J, Shao M, Zhao Y, Zeljic K, Gao G, Sun B. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System. Stereotact Funct Neurosurg. 2017;95(3):174-182. doi: 10.1159/000475765. Epub 2017 Jun 2.
PMID: 28571034BACKGROUNDZhang C, Li D, Zeljic K, Tan H, Ning Y, Sun B. A Remote and Wireless Deep Brain Stimulation Programming System. Neuromodulation. 2016 Jun;19(4):437-9. doi: 10.1111/ner.12448. No abstract available.
PMID: 27321195BACKGROUNDHeo MS, Moon HS, Kim HC, Park HW, Lim YH, Paek SH. Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease. J Korean Neurosurg Soc. 2015 Mar;57(3):152-8. doi: 10.3340/jkns.2015.57.3.152. Epub 2015 Mar 20.
PMID: 25810853BACKGROUNDHu WH, Zhang K, Meng FG, Ma Y, Zhang JG. Deep brain stimulation in China: present and future. Neuromodulation. 2012 May-Jun;15(3):251-9; discussion 259. doi: 10.1111/j.1525-1403.2012.00439.x. Epub 2012 Feb 29.
PMID: 22376211BACKGROUNDPerlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. doi: 10.1146/annurev.neuro.29.051605.112824.
PMID: 16776585BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Chencheng, MD
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of functional neurosurgery department
Study Record Dates
First Submitted
August 23, 2017
First Posted
August 30, 2017
Study Start
August 8, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 26, 2018
Record last verified: 2018-03