Parkinson's DiseasePhase 1NCT02601144

Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease

A Phase 1 study testing Deep Brain Stimulation in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Deep Brain Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesChina
Study dates: Oct 2015to Dec 2016
Phase: Phase 1
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 were receiving bilateral STN stimulation for more than six months.
They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
Subjects had an ability to walk at least 10 meters independently during ON DBS condition.

Who cannot join

gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
any change in the HFS DBS settings, three months prior to participation in the study.
complete inability to walk despite assistance while DBS ON.
Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
Subjects could not tolerate prolonged OFF medication condition.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Tsinghua University Yuquan Hospital
Beijing, Beijing Municipality, 100040
Beijing Tian Tan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease

This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).

Read the detailed description

HFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of them experienced loss of efficacy in the short term. Then comes to the little improvement or even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied. The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS and LFS.

Conditions: Parkinson's Disease
Being tested: Deep Brain Stimulation
Keywords: DBS, VFS, FOG
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deep Brain StimulationDevice
Deep Brain Stimulation

Study groups in NCT02601144
Study group	Role	What they receive
VFS	Experimental	variable frequency deep brain stimulation (VFS) Receives: Device: Deep Brain Stimulation
HFS	Active comparator	high frequency deep brain stimulation (HFS) Receives: Device: Deep Brain Stimulation
LFS	Active comparator	low frequency deep brain stimulation (LFS) Receives: Device: Deep Brain Stimulation
DBS off	No intervention	deep brain stimulation off

What is being measured

The primary outcome is the main question the study is designed to answer.

Timed Up and Go (TUG) task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Measured: The outcome of TUG task at 12 months follow-up.
the number of freezing episodes for TUG task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Measured: The outcome of TUG task at 12 months follow-up.

Secondary outcomes (5)

UPDRS III scores
Measured: Outcome of VFS at 6、12 months with reference to baseline HFS
Gait and Falls Questionnaire (GFQ) scores
Measured: Outcome of VFS at 6、12 months with reference to baseline HFS
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Measured: Outcome of VFS at 6、12 months with reference to baseline HFS
the Freezing of Gait Questionnaire (FOG-Q) scores
Measured: Outcome of VFS at 6 、12months with reference to baseline HFS
Number of adverse events (AE's)
Measured: Change from Baseline to 6、12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2016

First posted10 Nov 2015 (estimated)
Study startOct 2015
Primary completionDec 2016
Study completionDec 2016

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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02601144
Sponsor's protocol ID: PINS-014
Status last verified: Mar 2017
First submitted: 12 Oct 2015
Last updated: 21 Mar 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease
ClinicalTrials.gov ID: NCT02601144
Acronym / sponsor ID: PINS-014
Conditions: Parkinson's Disease
Keywords: DBS, VFS, FOG
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 10 Nov 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
VFS	Experimental	Device: Deep Brain Stimulationvariable frequency deep brain stimulation (VFS)
HFS	Active comparator	Device: Deep Brain Stimulationhigh frequency deep brain stimulation (HFS)
LFS	Active comparator	Device: Deep Brain Stimulationlow frequency deep brain stimulation (LFS)
DBS off	No intervention	–deep brain stimulation off

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients were receiving bilateral STN stimulation for more than six months.
They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
Subjects had an ability to walk at least 10 meters independently during ON DBS condition.

Key exclusion criteria (5 listed)

gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
any change in the HFS DBS settings, three months prior to participation in the study.
complete inability to walk despite assistance while DBS ON.
Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
Subjects could not tolerate prolonged OFF medication condition.

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
Deep Brain StimulationDeep Brain Stimulation	Device	HFS, LFS, VFS

Primary outcome

Timed Up and Go (TUG) task
Time frame: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
the number of freezing episodes for TUG task
Time frame: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)

5 secondary outcomes

UPDRS III scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Gait and Falls Questionnaire (GFQ) scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
the Freezing of Gait Questionnaire (FOG-Q) scores
Time frame: Outcome of VFS at 6 、12months with reference to baseline HFS
Number of adverse events (AE's)
Time frame: Change from Baseline to 6、12 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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, Ph.D study chair

Tsinghua University

Michael Okun, MD. study chair

University of Florida

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deep Brain Stimulation in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd at 2 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 3 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: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Timed Up and Go (TUG) task (time frame: The outcome of TUG task at 12 months follow-up.). The study lists 2 primary outcomes in all. 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 NCT02601144.

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 21 Mar 2017.