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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Parkinson Disease; Dystonia; Essential Tremor

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Jin Woo Chang; Phone Number: 82-02-2228-2150; Email: JCHANG@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Jin Woo Chang; Phone Number: 82-02-2228-2150; Email: JCHANG@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For those who need to replace the deep brain stimulation machine, and those who have given voluntary consent

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jin Woo Chang, Department of Neurosurgery, Brain Research Institute, Yonsei University College of Medicine, Seoul, South Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Anticipated): July 14, 2023
• Study Completion (Anticipated): February 14, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Dystonia; Essential Tremor
• Other Study ID Numbers: 1-2021-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No