The Safety of Remote DBS Programming System
Primary Purpose
Parkinson Disease
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SceneRay wireless and remote DBS system
Sponsored by
About this trial
This is an interventional device feasibility trial for Parkinson Disease
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.
Sites / Locations
- Shanghai Ruijin Hospital Functional Neurosurgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
remote programming system
Arm Description
Outcomes
Primary Outcome Measures
The Unified Parkinson's Disease Rating Scale III&IV
Deep Brain Stimulation Programming parameter
Contact selection
Deep Brain Stimulation Programming parameter
Pulse width
Deep Brain Stimulation Programming parameter
Frequency
Deep Brain Stimulation Programming parameter
Amplitude
Serious Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03267550
Brief Title
The Safety of Remote 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor terminated industrial support
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
March 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remote programming system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SceneRay wireless and remote DBS system
Intervention Description
Implement therapeutic programming in patients with network coverage at home
Primary Outcome Measure Information:
Title
The Unified Parkinson's Disease Rating Scale III&IV
Time Frame
Through study completion, an average of 4 months
Title
Deep Brain Stimulation Programming parameter
Description
Contact selection
Time Frame
Through study completion, an average of 4 months
Title
Deep Brain Stimulation Programming parameter
Description
Pulse width
Time Frame
Through study completion, an average of 4 months
Title
Deep Brain Stimulation Programming parameter
Description
Frequency
Time Frame
Through study completion, an average of 4 months
Title
Deep Brain Stimulation Programming parameter
Description
Amplitude
Time Frame
Through study completion, an average of 4 months
Title
Serious Adverse Event
Time Frame
Through study completion, an average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Chencheng, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital Functional Neurosurgery
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28571034
Citation
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.
Results Reference
background
PubMed Identifier
27321195
Citation
Zhang 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.
Results Reference
background
PubMed Identifier
25810853
Citation
Heo 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.
Results Reference
background
PubMed Identifier
22376211
Citation
Hu 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.
Results Reference
background
PubMed Identifier
16776585
Citation
Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. doi: 10.1146/annurev.neuro.29.051605.112824.
Results Reference
background
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The Safety of Remote DBS Programming System
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