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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04707638
• Other study ID #: NS20201230
• Status: Withdrawn
• Start date: January 1, 2021
• Est. completion date: January 11, 2023

Study information

• Verified date: January 2021
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Parkinson Disease

Intervention

Other:
• No intervention used
No intervention used

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Huazhong University of Science and Technology

References & Publications (2)

Tsai ST, Kuo CC, Chen TY, Chen SY. Neurophysiological comparisons of subthalamic deep-brain stimulation for Parkinson's disease between patients receiving general and local anesthesia. Ci Ji Yi Xue Za Zhi. 2016 Apr-Jun;28(2):63-67. doi: 10.1016/j.tcmj.2016.02.003. Epub 2016 Apr 10. — View Citation

Yamada K, Goto S, Kuratsu J, Matsuzaki K, Tamura T, Nagahiro S, Murase N, Shimazu H, Kaji R. Stereotactic surgery for subthalamic nucleus stimulation under general anesthesia: a retrospective evaluation of Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2007 Mar;13(2):101-7. Epub 2006 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS)	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.	Two years postoperatively
Primary	Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS)	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.	Two years postoperatively