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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04707638
Collaborator
Huazhong University of Science and Technology (Other)
0
24.3

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
0 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
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 :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 11, 2023
Anticipated Study Completion Date :
Jan 11, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Unified Parkinson's Disease Rating Scale (UPDRS) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wuhan Union Hospital, China
  • Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Fu Peng, PHD, Neurosurgery department of Wuhan Union Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT04707638
Other Study ID Numbers:
  • NS20201230
First Posted:
Jan 13, 2021
Last Update Posted:
Feb 3, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021