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Recruitment Status : Withdrawn (Ethics application has not been completed yet)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

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
Parkinson Disease Dystonia	Other: No intervention used

Detailed Description:

Study Design

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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

MedlinePlus Genetics related topics: Early-onset primary dystonia Dopa-responsive dystonia Parkinson disease

MedlinePlus related topics: Dystonia Parkinson's Disease

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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.
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.

Eligibility Criteria

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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:

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

Exclusion Criteria:

1.Patients without enough follow-up length.

Contacts and Locations

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

More Information

Publications:

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.

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.

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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

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