Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Variable Frequency Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Variable Frequency Stimulation
Eligibility Criteria
Inclusion Criteria:
- Patients With Idiopathic Parkinson's Disease.
- ≥18 years,both male and female
- Patients who under deep brain stimulation
- MMSE score ≥24
- H-Y≥2.0 under the medicine off/ constant frequency stimulation state
- The 14 item of UPDRS-II score ≥1
- The 15 item of UPDRS-II score ≥2
- Subjects had an ability to walk ≥ 10 meters independently under the medicine off/ constant frequency stimulation state
Exclusion Criteria:
- Pregnant women or breastfeeding mothers, or woman who cannot take effective measures to prevent pregnancy.
- Presence of other diseases affecting walking distance, such as joint disease in lower body, spinal disease, neuropathy, serious heart or lung disease.
- Diseases seriously affecting health and life, such as tumour, serious liver or kidney diseases etc.
- Patients with epilepsy etc.
- Presence of mental disorders or dementia.
- Patients or their families who cannot comprehend the therapy or patients who are unable to give informed consent voluntarily.
- Patients whom cannot cooperate well with follow-up requirements.
- Patients excluded based on the researchers judgement for participation in the clinical trial.
Sites / Locations
- Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting
- General Hospital of PLARecruiting
- Peking Union Medical College HospitalRecruiting
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
- Nanjing Brain Hospital Affiliated to Nanjing Medical UniversityRecruiting
- Changhai Hospital of ShanghaiRecruiting
- Huashan hospital, Fudan universityRecruiting
- The General Hospital of Shenyang MilitaryRecruiting
- Second People's Hospital of ShenzhenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Variable Frequency Stimulation
Constant Frequency Stimulation
Arm Description
Subjects in this group received variable frequency stimulation of deep brain stimulation
Subjects in this group received constant frequency stimulation of deep brain
Outcomes
Primary Outcome Measures
Stand-Walk-Sit
The total time of patients who complete the Stand-Walk-Sit task
Secondary Outcome Measures
United Parkinson's Disease Rate Scale scores
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
The Freezing of Gait Questionnaire (FOG-Q) scores
Gait and Falls Questionnaire (GFQ) scores
Full Information
NCT ID
NCT03053726
First Posted
January 22, 2017
Last Updated
March 13, 2018
Sponsor
Beijing Pins Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03053726
Brief Title
Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease
Official Title
Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease(RESTEP Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the VFS paradigm the stimulation frequency was set to alternate between high and low frequencies, where the frequency of stimulation or frequency combinations can be changed instantaneously according to damage of the moment rhythms. Variable frequency stimulation is a novel dynamic therapy which breaks through the existing single high-frequency stimulation paradigms. It is the world's first VFS therapy for the brain.
Detailed Description
In advanced stages of PD, motor symptoms and dyskinesia are effectively treated by deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) . Traditionally, in this procedure, stimulation is set to a constant frequency electrical stimulation with the physician programming the parameters of stimulation frequency, pulse width and amplitude, and stimulated patients' brain nuclei with single frequency, single pulse width and single amplitude of the electric stimulation. Indeed, high frequency stimulation (HFS) of the STN provides consistent, long-term improvement of the cardinal signs of PD . However, the treatment effects of HFS on the axial symptoms of PD, specifically FOG can be poor often causing further impairment. While this can be alleviated by using relatively low frequency stimulation (LFS) , major concerns in the clinical application of LFS exist in regards to its duration of therapeutic benefit. Previous studies have shown that LFS of the STN improves the axial motor signs in some PD patients, but a loss of therapeutic efficacy is seen in the short term. Thereafter, patients may present increased tremor, rigidity and bradykinesia, which is often intolerable outweighing the initial benefits of LFS therapy for FOG. As such, a suitable treatment strategy for FOG remains to be established.
Based on previous findings on the relationships between stimulation frequency and movement rhythm regulation in the human body, The National Engineering Laboratory for Neuromodulation, Tsinghua University, proposes a method of variable frequency stimulation (VFS) for aiding movement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Variable Frequency Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and the outcomes assessor are blinded in this study
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Variable Frequency Stimulation
Arm Type
Experimental
Arm Description
Subjects in this group received variable frequency stimulation of deep brain stimulation
Arm Title
Constant Frequency Stimulation
Arm Type
Sham Comparator
Arm Description
Subjects in this group received constant frequency stimulation of deep brain
Intervention Type
Procedure
Intervention Name(s)
Variable Frequency Stimulation
Intervention Description
vary the frequency of the stimulation parameter
Primary Outcome Measure Information:
Title
Stand-Walk-Sit
Description
The total time of patients who complete the Stand-Walk-Sit task
Time Frame
at 3 months compare to baseline
Secondary Outcome Measure Information:
Title
United Parkinson's Disease Rate Scale scores
Time Frame
at 3、6 months compare to baseline
Title
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time Frame
at 3、6 months compare to baseline
Title
The Freezing of Gait Questionnaire (FOG-Q) scores
Time Frame
at 3、6 months compare to baseline
Title
Gait and Falls Questionnaire (GFQ) scores
Time Frame
at 3、6 months compare to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients With Idiopathic Parkinson's Disease.
≥18 years,both male and female
Patients who under deep brain stimulation
MMSE score ≥24
H-Y≥2.0 under the medicine off/ constant frequency stimulation state
The 14 item of UPDRS-II score ≥1
The 15 item of UPDRS-II score ≥2
Subjects had an ability to walk ≥ 10 meters independently under the medicine off/ constant frequency stimulation state
Exclusion Criteria:
Pregnant women or breastfeeding mothers, or woman who cannot take effective measures to prevent pregnancy.
Presence of other diseases affecting walking distance, such as joint disease in lower body, spinal disease, neuropathy, serious heart or lung disease.
Diseases seriously affecting health and life, such as tumour, serious liver or kidney diseases etc.
Patients with epilepsy etc.
Presence of mental disorders or dementia.
Patients or their families who cannot comprehend the therapy or patients who are unable to give informed consent voluntarily.
Patients whom cannot cooperate well with follow-up requirements.
Patients excluded based on the researchers judgement for participation in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fumin Jia
Phone
010-60736388
Email
pins_medical@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luming Li
Phone
010-60736388
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luming Li
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD
Phone
010-67096767
Facility Name
General Hospital of PLA
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhipei Ling, MD
Phone
010-66938339
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Guo, MD
Phone
010-69152530
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanhua Liang
Phone
0411-83635963
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
Weiguo Liu, MD
Phone
025-82296071
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu, MD
Phone
021-31166666
Facility Name
Huashan hospital, Fudan university
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Wang, MD
Phone
021-96567576
Facility Name
The General Hospital of Shenyang Military
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqun Tao
Phone
024-28897782
Facility Name
Second People's Hospital of Shenzhen
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Cai, MD
Phone
0755-83216006
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31856908
Citation
Jia F, Zhang J, Wang H, Liang Z, Liu W, Wang X, Liu Y, Guo Y, Ling Z, Cai X, Wu X, Wu J, Lv W, Xu X, Zhang W, Li L. Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Dec 19;20(1):749. doi: 10.1186/s13063-019-3884-4.
Results Reference
derived
Learn more about this trial
Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease
We'll reach out to this number within 24 hrs