Clinical trial NCT06078397: Remote Programming for Deep Brain Stimulation in Parkinson's Disease.
Official title: Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Brain Stimulation
Parkinson Disease
Keywords: telemedicine
remote programming
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The unified Parkinson's disease rating scale (UPDRS) Part III
timeFrame: Preoperation and 6 months after surgery
measure: Cost-effectiveness
timeFrame: 6 months after surgery
Secondary outcomes:
measure: The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.
timeFrame: Preoperation and 6 months after surgery.
measure: Parkinson's Disease Questionaire-8 (PDQ-8)
timeFrame: Preoperation and 6 months after surgery.
measure: European Quality of Life 5 Dimensions 3 Level Version
timeFrame: Preoperation and 6 months after surgery.
measure: Beck Depression Inventory (BDI-II)
timeFrame: Preoperation and 6 months after surgery.
measure: Beck Anxiety Inventory (BAI)
timeFrame: Preoperation and 6 months after surgery.
measure: Mini-Mental State Examination (MMSE)
timeFrame: Preoperation and 6 months after surgery.
measure: Cost of patients' perspective
timeFrame: 6 months after surgery.
measure: Telehealth Satisfaction Survey (TeSS)
timeFrame: Collected within 2 days (48 hours) after each programming.
measure: The Patient Global Impression of Change (PGIC)
timeFrame: Collected within 2 days (48 hours) after each programming.
measure: Safety: Rate of programming related adverse events
timeFrame: Collected within 2 days (48 hours) after each programming.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References: