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Clinical Trials/NCT03230331
NCT03230331
Completed
Not Applicable

Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease

Ruijin Hospital1 site in 1 country20 target enrollmentJuly 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Ruijin Hospital
Enrollment
20
Locations
1
Primary Endpoint
Changs in the score of Stand-Walk-Sit Test
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.

Registry
clinicaltrials.gov
Start Date
July 24, 2017
End Date
May 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Haiyan Zhou

Principal Investigator

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

  • Idiopathic Parkinson's disease
  • Disease duration longer than 15 years
  • Had STN deep brain stimulation implant more than 10 years
  • Available and willing to be followed-up according to study protocol

Exclusion Criteria

  • Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
  • Pregnant female
  • History of severe neuropsychiatric disease
  • Patients are taking part in other clinical trials in recent several months

Outcomes

Primary Outcomes

Changs in the score of Stand-Walk-Sit Test

Time Frame: above 10 years post surgery

Secondary Outcomes

  • UPDRS part II score(above 10 years post surgery)
  • Freezing of Gait Questionnaire (FOG-Q) score(above 10 years post surgery)
  • Apathy Evaluation Scale score(above 10 years post surgery)
  • Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III(above 10 years post surgery)
  • 39-Item Parkinson´s Disease Questionnaire (PDQ-39) score(above 10 years post surgery)
  • Gait and Falls Questionnaire (GFQ) score(above 10 years post surgery)
  • Mini-Mental State Examination (MMSE) score(above 10 years post surgery)
  • Frontal Assessment Battery (FAB) score(above 10 years post surgery)
  • Hamilton Depression Scale-17 (HAMD-17) score(above 10 years post surgery)
  • UPDRS part I score(above 10 years post surgery)
  • UPDRS part IV score(above 10 years post surgery)
  • Montreal Cognitive Assessment (MoCA) Beijing score Version(above 10 years post surgery)
  • Hamilton Anxiety Scale (HAMA) score(above 10 years post surgery)

Study Sites (1)

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