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

NCT04707638 | Withdrawn

• 1 other identifier: NS20201230
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Dystonia

Keywords

Parkinson Disease; Dystonia; deep brain stimultation; neurophysiological characteristics

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

No intervention used OTHER

No intervention used

Parkinson's disease or dystonia patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients without enough follow-up length.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Huazhong University of Science and Technology: collaborator

Related 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. Tzu Chi Med J. 2016 Apr-Jun;28(2):63-67. doi: 10.1016/j.tcmj.2016.02.003. Epub 2016 Apr 10.

  PMID: 28757724 BACKGROUND

• 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. doi: 10.1016/j.parkreldis.2006.07.008. Epub 2006 Oct 19.

  PMID: 17055325 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fu Peng, PHD

  Neurosurgery department of Wuhan Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: January 1, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share