Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230331
• Other study ID #: FOGSTN
• Status: Completed
• Start date: July 24, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• Epilepsy

• Pregnant female

• History of severe neuropsychiatric disease

• Patients are taking part in other clinical trials in recent several months

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changs in the score of Stand-Walk-Sit Test		above 10 years post surgery
Secondary	Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III		above 10 years post surgery
Secondary	UPDRS part I score		above 10 years post surgery
Secondary	UPDRS part II score		above 10 years post surgery
Secondary	UPDRS part IV score		above 10 years post surgery
Secondary	39-Item Parkinson´s Disease Questionnaire (PDQ-39) score		above 10 years post surgery
Secondary	Freezing of Gait Questionnaire (FOG-Q) score		above 10 years post surgery
Secondary	Gait and Falls Questionnaire (GFQ) score		above 10 years post surgery
Secondary	Mini-Mental State Examination (MMSE) score		above 10 years post surgery
Secondary	Montreal Cognitive Assessment (MoCA) Beijing score Version		above 10 years post surgery
Secondary	Frontal Assessment Battery (FAB) score		above 10 years post surgery
Secondary	Hamilton Anxiety Scale (HAMA) score		above 10 years post surgery
Secondary	Hamilton Depression Scale-17 (HAMD-17) score		above 10 years post surgery
Secondary	Apathy Evaluation Scale score		above 10 years post surgery