Status:
UNKNOWN
Remote Programming for Deep Brain Stimulation in Parkinson's Disease.
Lead Sponsor:
Ruijin Hospital
Conditions:
Deep Brain Stimulation
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 programm...
Detailed Description
This is a randomized controlled trial aiming at comparing the efficacy of RP and SP in post-operative management of PD patients with DBS. Enrolled patients will be randomly assigned to the RP or SP gr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 × 1.5 m space for motion evaluation
- Other researchers believe that factors may not be suitable for research.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06078397
Start Date
October 30 2023
End Date
June 30 2025
Last Update
February 22 2024
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China