Parkinson DiseaseNCT03053726
Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease
A study testing Variable Frequency Stimulation in people with Parkinson Disease, run by Beijing Pins Medical Co., Ltd at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Variable Frequency Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 9 sitesChina
- Study dates
- 18 Aug 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
Luming Li contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Jianguo Zhang, MD, 010-67096767
- Recruiting
General Hospital of PLA
Beijing
Zhipei Ling, MD, 010-66938339
- Recruiting
Peking Union Medical College Hospital
Beijing
Yi Guo, MD, 010-69152530
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Zhanhua Liang, 0411-83635963
- Recruiting
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing
Weiguo Liu, MD, 025-82296071
- Recruiting
Changhai Hospital of Shanghai
Shanghai
Jianmin Liu, MD, 021-31166666
- Recruiting
Huashan hospital, Fudan university
Shanghai
Jian Wang, MD, 021-96567576
- Recruiting
The General Hospital of Shenyang Military
Shenyang
Yingqun Tao, 024-28897782
- Recruiting
Second People's Hospital of Shenzhen
Shenzhen
Xiaodong Cai, MD, 0755-83216006
About this study
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）
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Variable Frequency Stimulation
- Keywords
- Variable Frequency Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable Frequency StimulationProcedure or surgery
vary the frequency of the stimulation parameter
| Study group | Role | What they receive |
|---|---|---|
| Variable Frequency Stimulation | Experimental | Subjects in this group received variable frequency stimulation of deep brain stimulation Receives: Procedure: Variable Frequency Stimulation |
| Constant Frequency Stimulation | Sham comparator | Subjects in this group received constant frequency stimulation of deep brain Receives: Procedure: Variable Frequency Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stand-Walk-Sit
The total time of patients who complete the Stand-Walk-Sit task
Measured: at 3 months compare to baseline
Secondary outcomes (4)
United Parkinson's Disease Rate Scale scores
Measured: at 3、6 months compare to baseline
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Measured: at 3、6 months compare to baseline
The Freezing of Gait Questionnaire (FOG-Q) scores
Measured: at 3、6 months compare to baseline
Gait and Falls Questionnaire (GFQ) scores
Measured: at 3、6 months compare to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start18 Aug 2017
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luming Li, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053726
- Sponsor's protocol ID
- PINS-025
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31856908
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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）
- ClinicalTrials.gov ID
- NCT03053726
- Acronym / sponsor ID
- PINS-025
- Conditions
- Parkinson Disease
- Keywords
- Variable Frequency Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable Frequency Stimulation | Experimental | Procedure: Variable Frequency StimulationSubjects in this group received variable frequency stimulation of deep brain stimulation |
| Constant Frequency Stimulation | Sham comparator | Procedure: Variable Frequency StimulationSubjects in this group received constant frequency stimulation of deep brain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variable Frequency Stimulationvary the frequency of the stimulation parameter | Procedure or surgery | Constant Frequency Stimulation, Variable Frequency Stimulation |
Primary outcome
Stand-Walk-Sit
Time frame: at 3 months compare to baseline
The total time of patients who complete the Stand-Walk-Sit task
4 secondary outcomes
United Parkinson's Disease Rate Scale scores
Time frame: at 3、6 months compare to baseline
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: at 3、6 months compare to baseline
The Freezing of Gait Questionnaire (FOG-Q) scores
Time frame: at 3、6 months compare to baseline
Gait and Falls Questionnaire (GFQ) scores
Time frame: at 3、6 months compare to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Derived from this study: PubMed 31856908Jia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luming Li contact
Luming Li study chair
Tsinghua University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Frequency Stimulation in people with Parkinson Disease, run by Beijing Pins Medical Co., Ltd at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fumin Jia (010-60736388, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stand-Walk-Sit (time frame: at 3 months compare to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.