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Trial record 1 of 1 for:    NCT03053726
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Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03053726
Recruitment Status : Unknown
Verified March 2018 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : February 15, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: Variable Frequency Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients and the outcomes assessor are blinded in this study
Primary Purpose: Treatment
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)
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Variable Frequency Stimulation
Subjects in this group received variable frequency stimulation of deep brain stimulation
Procedure: Variable Frequency Stimulation
vary the frequency of the stimulation parameter

Sham Comparator: Constant Frequency Stimulation
Subjects in this group received constant frequency stimulation of deep brain
Procedure: Variable Frequency Stimulation
vary the frequency of the stimulation parameter




Primary Outcome Measures :
  1. Stand-Walk-Sit [ Time Frame: at 3 months compare to baseline ]
    The total time of patients who complete the Stand-Walk-Sit task


Secondary Outcome Measures :
  1. United Parkinson's Disease Rate Scale scores [ Time Frame: at 3、6 months compare to baseline ]
  2. The39-item Parkinson's Disease Questionnaire (PDQ-39) scores [ Time Frame: at 3、6 months compare to baseline ]
  3. The Freezing of Gait Questionnaire (FOG-Q) scores [ Time Frame: at 3、6 months compare to baseline ]
  4. Gait and Falls Questionnaire (GFQ) scores [ Time Frame: at 3、6 months compare to baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients With Idiopathic Parkinson's Disease.
  2. ≥18 years,both male and female
  3. Patients who under deep brain stimulation
  4. MMSE score ≥24
  5. H-Y≥2.0 under the medicine off/ constant frequency stimulation state
  6. The 14 item of UPDRS-II score ≥1
  7. The 15 item of UPDRS-II score ≥2
  8. Subjects had an ability to walk ≥ 10 meters independently under the medicine off/ constant frequency stimulation state

Exclusion Criteria:

  1. Pregnant women or breastfeeding mothers, or woman who cannot take effective measures to prevent pregnancy.
  2. Presence of other diseases affecting walking distance, such as joint disease in lower body, spinal disease, neuropathy, serious heart or lung disease.
  3. Diseases seriously affecting health and life, such as tumour, serious liver or kidney diseases etc.
  4. Patients with epilepsy etc.
  5. Presence of mental disorders or dementia.
  6. Patients or their families who cannot comprehend the therapy or patients who are unable to give informed consent voluntarily.
  7. Patients whom cannot cooperate well with follow-up requirements.
  8. Patients excluded based on the researchers judgement for participation in the clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053726


Contacts
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Contact: Fumin Jia 010-60736388 pins_medical@163.com
Contact: Luming Li 010-60736388

Locations
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China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Jianguo Zhang, MD    010-67096767      
China
General Hospital of PLA Recruiting
Beijing, China
Contact: Zhipei Ling, MD    010-66938339      
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Yi Guo, MD    010-69152530      
The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, China
Contact: Zhanhua Liang    0411-83635963      
Nanjing Brain Hospital Affiliated to Nanjing Medical University Recruiting
Nanjing, China
Contact: Weiguo Liu, MD    025-82296071      
Changhai Hospital of Shanghai Recruiting
Shanghai, China
Contact: Jianmin Liu, MD    021-31166666      
Huashan hospital, Fudan university Recruiting
Shanghai, China
Contact: Jian Wang, MD    021-96567576      
The General Hospital of Shenyang Military Recruiting
Shenyang, China
Contact: Yingqun Tao    024-28897782      
Second People's Hospital of Shenzhen Recruiting
Shenzhen, China
Contact: Xiaodong Cai, MD    0755-83216006      
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Investigators
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Study Chair: Luming Li Tsinghua University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT03053726    
Other Study ID Numbers: PINS-025
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Pins Medical Co., Ltd:
Variable Frequency Stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases