Remote Programming for Deep Brain Stimulation in Parkinson's Disease.

Last updated: February 20, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

remote programming

standard programming

Clinical Study ID

NCT06078397
RPDBSPD
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult primary Parkinson's disease patients who meet the diagnostic criteria forParkinson's disease in China (2016 edition), aged 18-75 years
  2. Comply with the surgical indications of the "Expert Consensus on Deep BrainStimulation Therapy for Parkinson's Disease in China (Second Edition)" and completebilateral 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 remotepostoperative management, and being able to participate in remote symptom assessmentand remote programming
  6. Able to communicate fluently, and after education, I and my caregivers are proficientin using the patient client of the remote program control system
  7. Understand potential risks/benefits, agree to participate in the study, studyprocedures, agree to complete the study follow-up, and comply with the requirements ofthe study protocol.

Exclusion

Exclusion Criteria:

  1. The preoperative concise mental state examination (MMSE) score of DBS indicatesmoderate 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 provideinformed consent for any reason
  4. Unable to provide stable network signal or unable to provide 4 × 1.5 m space formotion evaluation
  5. Other researchers believe that factors may not be suitable for research.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: remote programming
Phase:
Study Start date:
October 30, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

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