Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease
1 other identifier
interventional
106
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Aug 2017
Typical duration for not_applicable parkinson-disease
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedStudy Start
First participant enrolled
August 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 15, 2018
March 1, 2018
2 years
January 22, 2017
March 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stand-Walk-Sit
The total time of patients who complete the Stand-Walk-Sit task
at 3 months compare to baseline
Secondary Outcomes (4)
United Parkinson's Disease Rate Scale scores
at 3、6 months compare to baseline
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
at 3、6 months compare to baseline
The Freezing of Gait Questionnaire (FOG-Q) scores
at 3、6 months compare to baseline
Gait and Falls Questionnaire (GFQ) scores
at 3、6 months compare to baseline
Study Arms (2)
Variable Frequency Stimulation
EXPERIMENTALSubjects in this group received variable frequency stimulation of deep brain stimulation
Constant Frequency Stimulation
SHAM COMPARATORSubjects in this group received constant frequency stimulation of deep brain
Interventions
vary the frequency of the stimulation parameter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
General Hospital of PLA
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, China
Changhai Hospital of Shanghai
Shanghai, China
Huashan hospital, Fudan university
Shanghai, China
The General Hospital of Shenyang Military
Shenyang, China
Second People's Hospital of Shenzhen
Shenzhen, China
Related Publications (1)
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.
PMID: 31856908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luming Li
Tsinghua University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients and the outcomes assessor are blinded in this study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2017
First Posted
February 15, 2017
Study Start
August 18, 2017
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
March 15, 2018
Record last verified: 2018-03