Parkinson's DiseasePhase 2NCT02929628
Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease
A Phase 2 study testing Beijing PINS Programming in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd.
Trial summary
Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore >1 for UPDRS part II item 14; permissions given by… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Beijing PINS Programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Nov 2017
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years of age,male or female patients
- idiopathic Parkinson's disease
- had deep brain stimulaton implant
- H-Y>2.0 in the absence of L-dopa
- UPDRSII-14 item ≥1
- UPDRSII-15 item ≥2
- an ability to walk at least 10 meters independently
Who cannot join
- Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- epilepsy
- Pregnant female
- History of severe neuropsychiatric disease
- Patients are taking part in other clinical trials in recent several months
About this study
Official title: Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore >1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.
- Conditions
- Parkinson's Disease
- Being tested
- Beijing PINS Programming
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beijing PINS ProgrammingDevice
Using the programming control the Stimulator to change the parameter
| Study group | Role | What they receive |
|---|---|---|
| Patients with Various Frequency Stimulation | Experimental | Patients are in the condition of Various Frequency Stimulation Receives: Device: Beijing PINS Programming |
| Patients With Traditional Frequency Stimulation | Sham comparator | Patients in the condition of Sham Comparator are Traditional Frequency Stimulation Receives: Device: Beijing PINS Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changs in the score of Stand-Walk-Sit Test
Measured: 1、3、6 and 12 month
Secondary outcomes (3)
Change of the score in UPDRS
Measured: 1,3,6,12 months of Various Frequency Stimulation
Change of the score in PDQ-39
Measured: 1、3、6、12 months of Various Frequency Stimulation
Change of the score in the FOG-Q
Measured: 1、3、6、12 month of Various Frequency Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929628
- Sponsor's protocol ID
- PINS-020
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02929628
- Acronym / sponsor ID
- PINS-020
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- 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.
Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore >1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Various Frequency Stimulation | Experimental | Device: Beijing PINS ProgrammingPatients are in the condition of Various Frequency Stimulation |
| Patients With Traditional Frequency Stimulation | Sham comparator | Device: Beijing PINS ProgrammingPatients in the condition of Sham Comparator are Traditional Frequency Stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years of age,male or female patients
- idiopathic Parkinson's disease
- had deep brain stimulaton implant
- H-Y>2.0 in the absence of L-dopa
- UPDRSII-14 item ≥1
Key exclusion criteria (5 listed)
- Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- epilepsy
- Pregnant female
- History of severe neuropsychiatric disease
- Patients are taking part in other clinical trials in recent several months
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 |
|---|---|---|
| Beijing PINS ProgrammingUsing the programming control the Stimulator to change the parameter | Device | Patients With Traditional Frequency Stimulation, Patients with Various Frequency Stimulation |
Primary outcome
Changs in the score of Stand-Walk-Sit Test
Time frame: 1、3、6 and 12 month
3 secondary outcomes
Change of the score in UPDRS
Time frame: 1,3,6,12 months of Various Frequency Stimulation
Change of the score in PDQ-39
Time frame: 1、3、6、12 months of Various Frequency Stimulation
Change of the score in the FOG-Q
Time frame: 1、3、6、12 month of Various Frequency Stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beijing PINS Programming in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd.
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 7 inclusion and 5 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changs in the score of Stand-Walk-Sit Test (time frame: 1、3、6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2016.