Remote Programming for Deep Brain Stimulation in Parkinson's Disease.
REPRO-PD
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFebruary 22, 2024
August 1, 2023
1.3 years
September 20, 2023
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The unified Parkinson's disease rating scale (UPDRS) Part III
The unified Parkinson's disease rating scale (UPDRS) Part III is made up of motor examinations (18 items). Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Score range: 0-132, 32 and below is mild, 59 and above is severe.
Preoperation and 6 months after surgery
Cost-effectiveness
Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.
6 months after surgery
Secondary Outcomes (10)
The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.
Preoperation and 6 months after surgery.
Parkinson's Disease Questionaire-8 (PDQ-8)
Preoperation and 6 months after surgery.
European Quality of Life 5 Dimensions 3 Level Version
Preoperation and 6 months after surgery.
Beck Depression Inventory (BDI-II)
Preoperation and 6 months after surgery.
Beck Anxiety Inventory (BAI)
Preoperation and 6 months after surgery.
- +5 more secondary outcomes
Study Arms (2)
the Remote Programming (RP) group
EXPERIMENTALAfter 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
the Standard Programming (SP) group
ACTIVE COMPARATORAfter implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery
Interventions
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.
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
You may qualify if:
- Adult primary Parkinson's disease patients who meet the diagnostic criteria for Parkinson's disease in China (2016 edition), aged 18-75 years
- 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
- Accurate lead position verified by postoperative CT examination
- The implanted DBS device has remote programming function
- 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
- Able to communicate fluently, and after education, I and my caregivers are proficient in using the patient client of the remote program control system
- 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.
You may not qualify if:
- The preoperative concise mental state examination (MMSE) score of DBS indicates moderate or above cognitive impairment
- Severe complications after DBS surgery, such as stroke, encephalitis, wound infection, etc.
- Lack of cooperation, or inability to understand the experimental plan or provide informed consent for any reason
- Unable to provide stable network signal or unable to provide 4 Ă— 1.5 m space for motion evaluation
- Other researchers believe that factors may not be suitable for research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
October 11, 2023
Study Start
October 30, 2023
Primary Completion
January 30, 2025
Study Completion
June 30, 2025
Last Updated
February 22, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share