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NCT Number: NCT04361188

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

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.

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Key information

Conditions

Parkinson Disease Anesthesia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAC anesthesia

Procedure

Patients receives DBS under monitored anesthesia care.

AAA anesthesia

Procedure

Patients receives DBS under asleep-awake-asleep anesthesia.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change of Levodopa Equivalent Dose

    Time frame: Before and six-month after DBS.

    Compares the change of Levodopa equivalent dose between the two groups.

  2. Rates of Adverse Events

    Time frame: Intra-operative.

    Compares the rates of adverse events between the two groups.

  3. Dosage of Anesthetic Drugs

    Time frame: Within surgery.

    Compares the dosage of anesthetic between the two groups.

  4. Wake-up Time

    Time frame: Within surgery.

    Compares the wake-up time between the two groups.

  5. Surgical Time

    Time frame: Within surgery.

    Compares the surgical time between the two groups.

  6. Hoehn&Yahr

    Time frame: Before surgery.

    Compares the Hoehn&Yahr classification between the two groups' patients.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Shenzhen Second People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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