NCT05550714 Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease
| NCT ID | NCT05550714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | PD - Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2024-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2022-10-15 with a primary completion date of 2024-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
Eligibility Criteria
Inclusion Criteria: 1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent. Exclusion Criteria: 1. Obstructive sleep apnea; 2. BMI \> 30kg/m2; 3. Estimated difficult airway; 4. Severe preoperative anxiety; 5. Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction) 6. A history of allergy to the anaesthetics.
Contact & Investigator
Ruquan Han, MD, PhD
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05550714 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying PD - Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05550714 currently recruiting?
Yes, NCT05550714 is actively recruiting participants. Contact the research team at ruquan.han@gmail.com for enrollment information.
Where is the NCT05550714 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05550714 clinical trial?
NCT05550714 is sponsored by Beijing Tiantan Hospital. The principal investigator is Ruquan Han, MD, PhD at Beijing Tiantan Hospital. The trial plans to enroll 188 participants.
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