UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia

Study Overview
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Brief Summary
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Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.

Detailed Description
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Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.

Official Title
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UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial

Conditions
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Parkinson Disease, Anesthesia

Intervention / Treatment
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* Procedure: MAC anesthesia
* Procedure: AAA anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years old Diagnosis of primary Parkinson's disease Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications. Exclusion Criteria: Refusal to Participate in the research Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder Previous functional neurosurgery: DBS, thalamic incision, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAC anesthesia group<br>Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia. | Procedure: MAC anesthesia<br>* Patients receives DBS under monitored anesthesia care.<br>|
| Active Comparator: AAA anesthesia group<br>Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia. | Procedure: AAA anesthesia<br>* Patients receives DBS under asleep-awake-asleep anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores' change of Unified Parkinson's Rating Scale (part III/motor part) | Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups. | Before and six-month after DBS. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Levodopa Equivalent Dose | Compares the change of Levodopa equivalent dose between the two groups. | Before and six-month after DBS. | 
| Rates of Adverse Events | Compares the rates of adverse events between the two groups. | Intra-operative. | 
| Dosage of Anesthetic Drugs | Compares the dosage of anesthetic between the two groups. | Within surgery. | 
| Wake-up Time | Compares the wake-up time between the two groups. | Within surgery. | 
| Surgical Time | Compares the surgical time between the two groups. | Within surgery. | 
| Hoehn&Yahr | Compares the Hoehn&Yahr classification between the two groups' patients. | Before surgery. | 
| Patients' Satisfaction(Visual Analogue Scale) | Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction. | 24 hours after surgery. | 
| Scores' change of 39-item Parkinson's Disease Questionnaire | Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups. | Before and six-month after DBS. | 
| Scores' change of Mini-mental State Examination | Compares the scores' change of Mini-mental State Examination between the two groups. | Before and six-month after DBS. | 
| Scores' change of Montreal Cognitive Assessment | Compares the scores' change of Montreal Cognitive Assessment between the two groups. | Before and six-month after DBS. | 
| Scores' change of Hamilton Anxiety Scale | Compares the scores' change of Hamilton Anxiety Scale between the two groups. | Before and six-month after DBS. | 
| Scores' change of Hamilton Depression Scale | Compares the scores' change of Hamilton Depression Scale between the two groups. | Before and six-month after DBS. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAC, Parkinson's disease, UPDRS-III, Deep Brain Stimulation, AAA