Remote programming for managing Parkinson's disease after surgery
Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study
This study tests if using remote programming can help improve movement in people with Parkinson's disease after they have surgery, compared to regular in-person programming.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06078397 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of remote programming (RP) versus standard programming (SP) for improving motor function in patients with Parkinson's disease who have undergone deep brain stimulation (DBS) surgery. Participants will be randomly assigned to either the RP or SP group and will receive regular programming sessions post-surgery. The study will assess motor symptom improvement over a six-month follow-up period, along with evaluating safety and economic benefits of both programming methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with primary Parkinson's disease who have undergone bilateral STN-DBS surgery and have access to the internet for remote management.
Not a fit: Patients who do not have access to the internet or are unable to participate in remote assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of Parkinson's disease by providing a more effective and convenient method for post-surgical care.
How similar studies have performed: Other studies have shown promising results with remote programming approaches in similar contexts, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Dianyou Li, MD, PhD
- Email: ldy11483@rjh.com.cn
- Phone: (021)64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.