Remote Programming for Deep Brain Stimulation in Parkinson's Disease. (REPRO-PD)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Parkinson Disease; Deep Brain Stimulation

Treatments: Device: standard programming; Device: remote programming

Study type: Interventional

Funder types: Other

Identifiers

NCT06078397

RPDBSPD

Details and patient eligibility

About

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).

Full 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 groups before surgery. After recording baseline data, regular programming sessions will be conducted through RP or SP. Patients will be followed up in 6 months after implantation, with the main goal of the differences in motor symptom improvement between the two groups and the secondary goal of the difference in safety and economic benefits between both methods.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult primary Parkinson's disease patients who meet the diagnostic criteria for Parkinson's disease in China (2016 edition), aged 18-75 years
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

1. The preoperative concise mental state examination (MMSE) score of DBS indicates moderate or above cognitive impairment
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

the Remote Programming (RP) group

Experimental group

Description:

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

Treatment:

Device: remote programming

the Standard Programming (SP) group

Active Comparator group

Description:

After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery

Treatment:

Device: standard programming