Comparison of the Electric Plasma Surgical Tool PlasmaBlade for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery

Study Overview
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Brief Summary
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The deep brain stimulation is surgical technique used for the Parkinson's disease, essential tremor, dystonia, epilepsy, and psychiatric diseases. A pulse generator or battery (implanted pulse generator, IPG) is a need for replacement every few years. In general, electric cautery(BOVIE), which is commonly used in surgery, cannot be used when the deep brain stimulation machine is inserted, so conventional tools such as scissors and knives are used for replacement surgery. However, in the process, damage to the machine may be inflicted by knives, scissors, etc., and in the worst case, the machine may be unusable, resulting in financial and human consumption. Plasma Blade is currently used for tissue incision and coagulation in Korea, and is the only insurance-recognized tool in Korea for the replacement surgery of a cardiovascular implantable electronic device (CIED). The deep brain stimulation machine has a structure very similar to that of the heart electronics. In addition, the plasma blade was used to replace the deep brain stimulation machine overseas.The safety is reported in the surgery, so the plasma blade deep brain stimulation machine has been replaced in Korea. The investigators would like to check the safety and effectiveness for use in surgery.

Official Title
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Comparison of the Electric Plasma Surgical Tool PlasmaBlade for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery

Conditions
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Parkinson Disease, Essential Tremor, Dystonia, Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over the age of 19 Those who voluntarily agree to participate in this clinical trial and are willing to comply with the clinical trial protocol Persons who have previously undergone deep brain stimulation for Parkinson's disease, essential tremor, dystonia, epilepsy, etc. Those who need replacement of deep brain stimulation machine Exclusion Criteria: Those who cannot be under general anesthesia

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications occurred during surgery | Evaluate mechanical damage to the DBS machine immediately after surgery | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | Check the time required for surgery | Intraoperative | 
| The occurrence of wound-related complications | the occurrence of short-term/long-term complications (hematoma, infection, wound spread, and changes in mechanical resistance values) the 1 day after surgery, 3 weeks after surgery, and 6 months after surgery | The 1 day after surgery, 3 weeks after surgery, 6 months after surgery |