Clinical trial NCT05535556: Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery
Official title: Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Essential Tremor
Dystonia
Epilepsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Complications occurred during surgery
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Surgical time
timeFrame: Intraoperative
measure: The occurrence of wound-related complications
timeFrame: The 1 day after surgery, 3 weeks after surgery, 6 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Neurosurgery, Brain Research Institute, Yonsei University College of Medicine, Seoul, South Korea
name: Jin Woo Chang
role: PRINCIPAL_INVESTIGATOR
References: