Remote Programming for Deep Brain Stimulation in Parkinson's Disease.
NCT ID: NCT06078397
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-10-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the Remote Programming (RP) group
After implantation of DBS and train for RP in hospital, regularly receive RP instead of in-visit SP for parameter adjustment in 1, 3, 6 month after surgery
remote programming
Remote programming (RP) is a new type of patient management method after DBS surgery, which allows physicians to understand the patient's movement symptoms and adjust parameters through video conferencing. At the same time, the RP system also includes device checks, medication adjustments, psychological counseling, and other contents. Compared to standard programming that requires going to the hospital, the application of RP can save the burden on patients and their caregivers.
the Standard Programming (SP) group
After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery
standard programming
Programming refers to a series of methods that set the parameters of the IPG after the implantation of DBS, and adjust the device parameters based on the patient's symptoms during subsequent follow-up to maintain the efficacy of electrical stimulation.
Interventions
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remote programming
Remote programming (RP) is a new type of patient management method after DBS surgery, which allows physicians to understand the patient's movement symptoms and adjust parameters through video conferencing. At the same time, the RP system also includes device checks, medication adjustments, psychological counseling, and other contents. Compared to standard programming that requires going to the hospital, the application of RP can save the burden on patients and their caregivers.
standard programming
Programming refers to a series of methods that set the parameters of the IPG after the implantation of DBS, and adjust the device parameters based on the patient's symptoms during subsequent follow-up to maintain the efficacy of electrical stimulation.
Eligibility Criteria
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Inclusion Criteria
2. Comply with the surgical indications of the "Expert Consensus on Deep Brain Stimulation Therapy for Parkinson's Disease in China (Second Edition)" and complete bilateral STN-DBS surgery
3. Accurate lead position verified by postoperative CT examination
4. The implanted DBS device has remote programming function
5. Having an internet connection at home or in the area that will receive remote postoperative management, and being able to participate in remote symptom assessment and remote programming
6. Able to communicate fluently, and after education, I and my caregivers are proficient in using the patient client of the remote program control system
7. Understand potential risks/benefits, agree to participate in the study, study procedures, agree to complete the study follow-up, and comply with the requirements of the study protocol.
Exclusion Criteria
2. Severe complications after DBS surgery, such as stroke, encephalitis, wound infection, etc.
3. Lack of cooperation, or inability to understand the experimental plan or provide informed consent for any reason
4. Unable to provide stable network signal or unable to provide 4 × 1.5 m space for motion evaluation
5. Other researchers believe that factors may not be suitable for research.
18 Years
75 Years
ALL
Yes
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RPDBSPD
Identifier Type: -
Identifier Source: org_study_id
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