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

Yonsei University

Status: Enrolling

Conditions: Epilepsy; Essential Tremor; Dystonia; Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05535556

1-2021-0063

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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