Effects of Bilateral GPI DBS on Freezing of Gait in PD

Parkinson Disease Clinical Trial

— PD GPI DBS  

Official title:

Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227250
• Other study ID #: GPIFOG
• Status: Recruiting
• Start date: July 24, 2017
• Est. completion date: August 2020

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: Haiyan Zhou
• Phone: +8602134188108
• Email: zhaiyan.com[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age >18 years of age,male or female patients

• Idiopathic Parkinson's disease with freezing of gait

• Had GPI deep brain stimulation implant

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
Haiyan Zhou

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		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the scores in UPDRS		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in PDQ-39		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in the Freezing of Gait Questionnaire (FOG-Q)		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in the Gait and Falls Questionnaire (GFQ)		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in the Mini-Mental State Examination (MMSE)		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in the Montreal Cognitive Assessment (MoCA) Beijing Version		baseline, 3month, 6month, 9month, 12 month
Secondary	Change of the score in the Frontal Assessment Battery (FAB)		baseline, 3month, 6month, 9month, 12 month