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NCT Number: NCT06494956

To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease

To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Aged 18-70 years old, patients with primary Parkinson's disease;2. The duration of Parkinson's disease is 5 years or more;3. The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages;4. UPDRS motion score ≥30 in "Off" state;5. Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);6. The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;7. MMSE score ≥24 points on the simple intelligent mental state Examination Scale;8. Have the ability of independent external charging operation;9. Patients or their family members can fully understand the treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.

Exclusion criteria

1. Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;2. The "off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;3. There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;4. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.

Treatment and study plan

Implant device

Procedure

A subcutaneous tunnel was established under general anesthesia, the electrode was connected to the stimulator, and the pulse generator was implanted in the skull.

Primary outcomes

  1. Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary

    Time frame: 7 months

    Subjects fill in diary cards

  2. Subjects fill in a diary card after device implantation

    Time frame: 6 months

    Subjects fill in diary cards

  3. Drug dosage evaluation

    Time frame: 7 months

    Subjects fill in diary cards

  4. Charging performance evaluation

    Time frame: 6 months

    Subjects fill in diary cards

Sponsors and collaborators

Lead sponsor

Jiangsu CED Medtech Co., Ltd

Industry

Registry information

Official study title

A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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