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Closed-loop DBS in Parkinson's Disease

NCT06012461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-05

No results posted yet for this study

Summary

Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.

Conditions

  • Parkinson Disease

Interventions

OTHER

Closed-loop DBS stimulation for 24 hours

Continuous closed-loop modulation for 24 hours

OTHER

Open-loop DBS stimulation for 24 hours

Continuous open-loop modulation for 24 hours

OTHER

Closed-loop DBS stimulation for 72 hours

Continuous closed-loop modulation for 72 hours

OTHER

Open-loop DBS stimulation for 72 hours

Continuous open-loop modulation for 72 hours

Sponsors & Collaborators

  • National Engineering Research Center of Neuromodulation, Tsinghua University

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY

  • Tsinghua University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012461 on ClinicalTrials.gov