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

August 16, 2021 updated by: ZhiHeng Liu, Shenzhen Second People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MAC anesthesia group
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Procedure: MAC anesthesia
Patients receives DBS under monitored anesthesia care.
ACTIVE_COMPARATOR: AAA anesthesia group
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Procedure: AAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
Time Frame: Before and six-month after DBS.
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
Time Frame: Before and six-month after DBS.
Compares the change of Levodopa equivalent dose between the two groups.
Before and six-month after DBS.
Rates of Adverse Events
Time Frame: Intra-operative.
Compares the rates of adverse events between the two groups.
Intra-operative.
Dosage of Anesthetic Drugs
Time Frame: Within surgery.
Compares the dosage of anesthetic between the two groups.
Within surgery.
Wake-up Time
Time Frame: Within surgery.
Compares the wake-up time between the two groups.
Within surgery.
Surgical Time
Time Frame: Within surgery.
Compares the surgical time between the two groups.
Within surgery.
Hoehn&Yahr
Time Frame: Before surgery.
Compares the Hoehn&Yahr classification between the two groups' patients.
Before surgery.
Patients' Satisfaction(Visual Analogue Scale)
Time Frame: 24 hours after surgery.
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
Time Frame: Before and six-month after DBS.
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
Time Frame: Before and six-month after DBS.
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
Time Frame: Before and six-month after DBS.
Compares the scores' change of Montreal Cognitive Assessment between the two groups.
Before and six-month after DBS.
Scores' change of Hamilton Anxiety Scale
Time Frame: Before and six-month after DBS.
Compares the scores' change of Hamilton Anxiety Scale between the two groups.
Before and six-month after DBS.
Scores' change of Hamilton Depression Scale
Time Frame: Before and six-month after DBS.
Compares the scores' change of Hamilton Depression Scale between the two groups.
Before and six-month after DBS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FS20191119007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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