Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02929628
• Other study ID #: PINS-020
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 8, 2016
• Last updated: October 12, 2016
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition＞2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore ＞1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

• idiopathic Parkinson's disease

• had deep brain stimulaton implant

• H-Y>2.0 in the absence of L-dopa

• UPDRSII-14 item =1

• UPDRSII-15 item =2

• an ability to walk at least 10 meters independently

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Beijing PINS Programming
Using the programming control the Stimulator to change the parameter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changs in the score of Stand-Walk-Sit Test		1?3?6 and 12 month	Yes
Secondary	Change of the score in UPDRS		1,3,6,12 months of Various Frequency Stimulation	Yes
Secondary	Change of the score in PDQ-39		1?3?6?12 months of Various Frequency Stimulation	Yes
Secondary	Change of the score in the FOG-Q		1?3?6?12 month of Various Frequency Stimulation	Yes