Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543563
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinsons DiseaseASPIREA Randomized Controlled Double-blind Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPIRE
Brief Summary:
Under regional anesthesia subthalamic nucleus deep brain stimulation STN-DBS has proven to be an effective therapeutic approach for improving motor symptoms in Parkinsons disease However a significant portion of Parkinsons disease PD patients is unable to cooperate with the surgery necessitating the use of awake sedation Nevertheless the administration of anesthetic drugs often impacts the electrical signals recorded by microelectrodes to varying degrees This study is designed as a prospective randomized placebo-controlled double-blind two-arm investigation PD patients scheduled for bilateral STN-DBS surgery will be randomly assigned to either the Dexmedetomidine group or the Dexmedetomidine combined with Esketamine group The differences in neural activity between the two groups will be assessed using the normalized root mean square NRMS method The primary outcome measure is NRMS while secondary outcome measures include differences in beta oscillation power spectrum analysis postoperative delirium incidence postoperative changes in sleep disturbances postoperative depression anxiety status and occurrence of adverse events
Detailed Description:
Regional anesthesia for subthalamic nucleus deep brain stimulation STN-DBS is an effective treatment method for improving motor symptoms in Parkinsons disease However the majority of Parkinsons disease PD patients require awake sedation during the procedure Nevertheless the administration of anesthetic drugs often impacts the microelectrode recording MER signals to varying degrees Current research suggests that Esketamine can provide sedation and analgesia while preserving the active brain electrical signals of patients Additionally it has been shown to improve sleep disturbances and alleviate depression and anxiety in patientsThis study aims to compare the impact of Dexmedetomidine alone and Dexmedetomidine combined with Esketamine on MER during awake sedation in PD patients undergoing STN-DBS surgery to clarify the influence of Esketamine on the intraoperative electrical signals of PD patients under awake sedation during DBS surgery The experiment is designed as a prospective randomized placebo-controlled non-inferiority study with a double-blind two-arm design PD patients scheduled for bilateral STN-DBS surgery will be randomly assigned to either the Dexmedetomidine group or the Dexmedetomidine combined with Esketamine group The differences in neural activity between the two groups will be assessed using the normalized root mean square NRMS method The primary outcome measure is NRMS while secondary outcome measures include differences in beta oscillation power spectrum analysis postoperative delirium incidence postoperative changes in sleep disturbances postoperative depression anxiety status and occurrence of adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None