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Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Directional deep brain stimualtion
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age at the time of enrollment: 18 ~ 75; Idiopathic Parkinson's disease; Patient whose symptoms are not adequately controlled by best medical therapy; Hoehn and Yahr stage≥2.5; Patient whose symptoms are improved by at least 30% with levodopa challenge test; Must be an appropriate candidate for the surgical procedures required for bilateral DBS; Is willing and able to comply with all visits and study related procedures; Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Exclusion Criteria: Had received lesioning surgical treatment; A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception; Any current drug or alcohol abuse; Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above); Any significant psychiatric problems, including unrelated clinically significant depression; Any history of craniocerebral injury, tumor, or severe cerebrovascular disease; Severe brain atrophy (confirmed by CT or MRI); A condition requiring or likely to require the use of diathermy; Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function; Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases; Long-term of immunosuppressive or hormone therapy; Other diseases requiring the stimulators; A condition requiring or likely to require the use of MRI; Participated in any other clinical trials within the preceding 3 months; Unwilling or unable to cooperate with the implantation of DBS system; Unwilling or unable to cooperate with postoperative follow-up; Not considered to be applicable by the investigator.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University
  • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
  • West China Hospital of Sichuan UniversityRecruiting
  • First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Nanjing Brain Hospital Affiliated to Nanjing Medical UniversityRecruiting
  • Changhai Hospital, the Second Military Medical UniversityRecruiting
  • Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
  • Tianjin Medical University General Hospital
  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Directional deep brain stimulation

Arm Description

Outcomes

Primary Outcome Measures

Therapeutic Window
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.

Secondary Outcome Measures

Motor Function
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.
Quality of Life
Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.
Total Electrical Energy Delivered(TEED)
TEED=(Voltage^2×frequency×pulse width)/impedance×1 s
The dosage of anti-parkinsonian medications
On time(h/d) without troublesome dyskinesia
Adverse events

Full Information

First Posted
August 1, 2023
Last Updated
September 14, 2023
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital, Changhai Hospital, the Second Military Medical University, Shenzhen Second People's Hospital, Wuhan University, West China Hospital, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, First Affiliated Hospital of Kunming Medical University, Nanjing Medical University, Tianjin Medical University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05992701
Brief Title
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Official Title
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital, Changhai Hospital, the Second Military Medical University, Shenzhen Second People's Hospital, Wuhan University, West China Hospital, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, First Affiliated Hospital of Kunming Medical University, Nanjing Medical University, Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and related system components.
Detailed Description
This is a prospective, open label, non-randomized study. The study will evaluate the clinical outcome and possible adverse effects of the directional DBS treatment. The following data will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Directional deep brain stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Directional deep brain stimualtion
Intervention Description
Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.).
Primary Outcome Measure Information:
Title
Therapeutic Window
Description
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.
Time Frame
1 month post the device implanted
Secondary Outcome Measure Information:
Title
Motor Function
Description
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.
Time Frame
3 months post device-activation
Title
Quality of Life
Description
Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.
Time Frame
3 months post device-activation
Title
Total Electrical Energy Delivered(TEED)
Description
TEED=(Voltage^2×frequency×pulse width)/impedance×1 s
Time Frame
3 months post device-activation
Title
The dosage of anti-parkinsonian medications
Time Frame
3 months post device-activation
Title
On time(h/d) without troublesome dyskinesia
Time Frame
3 months post device-activation
Title
Adverse events
Time Frame
3 months post device-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at the time of enrollment: 18 ~ 75; Idiopathic Parkinson's disease; Patient whose symptoms are not adequately controlled by best medical therapy; Hoehn and Yahr stage≥2.5; Patient whose symptoms are improved by at least 30% with levodopa challenge test; Must be an appropriate candidate for the surgical procedures required for bilateral DBS; Is willing and able to comply with all visits and study related procedures; Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Exclusion Criteria: Had received lesioning surgical treatment; A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception; Any current drug or alcohol abuse; Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above); Any significant psychiatric problems, including unrelated clinically significant depression; Any history of craniocerebral injury, tumor, or severe cerebrovascular disease; Severe brain atrophy (confirmed by CT or MRI); A condition requiring or likely to require the use of diathermy; Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function; Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases; Long-term of immunosuppressive or hormone therapy; Other diseases requiring the stimulators; A condition requiring or likely to require the use of MRI; Participated in any other clinical trials within the preceding 3 months; Unwilling or unable to cooperate with the implantation of DBS system; Unwilling or unable to cooperate with postoperative follow-up; Not considered to be applicable by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianguang Sun
Phone
010-60736388
Email
sunjianguang@pinsmedical.com
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
City
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hualin Yu
Facility Name
Nanjing Brain Hospital Affiliated to Nanjing Medical University
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Zhang
Facility Name
Changhai Hospital, the Second Military Medical University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wu
Facility Name
Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
City
Shenzhen
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

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