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Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)

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ClinicalTrials.gov Identifier: NCT04707638
Recruitment Status : Withdrawn (Ethics application has not been completed yet)
First Posted : January 13, 2021
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Wuhan Union Hospital, China

Brief Summary:
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.

Condition or disease Intervention/treatment
Parkinson Disease Dystonia Other: No intervention used

Detailed Description:
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 11, 2023
Estimated Study Completion Date : January 11, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease or dystonia patients
Patients with Parkinson's disease or dystonia and underwent STN DBS under general anesthesia in neurosurgery department
Other: No intervention used
No intervention used




Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Two years postoperatively ]
    UPDRS has four parts: part I (nonmotor experiences of daily living, total score=16); part II (patient motor experience of daily living, total score=52); part III (clinician motor examination, total score=56); part IV (complications, total score=23). The total score of all the four parts is147. Higher scores means a worse outcome.

  2. Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS) [ Time Frame: Two years postoperatively ]
    BFMDRS has two parts: BFMDRS movement part (BFMDRS-M) and BFMDRS disability part (BFMDRS-D). The total score of BFMDRS-M is 120 and the total score of BFMDRS-D is 30. Higher scores means a worse outcome.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease or dystonia and STN-DBS in neurosurgery department of Wuhan Union Hospital.
Criteria

Inclusion Criteria:

  1. Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
  2. Patients with Parkinson's disease or dystonia.

Exclusion Criteria:

1.Patients without enough follow-up length.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707638


Sponsors and Collaborators
Wuhan Union Hospital, China
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Fu Peng, PHD Neurosurgery department of Wuhan Union Hospital
Publications:
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Responsible Party: Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04707638    
Other Study ID Numbers: NS20201230
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuhan Union Hospital, China:
Parkinson Disease
Dystonia
deep brain stimultation
neurophysiological characteristics
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations