Parkinson DiseaseNCT05292794
Use of CereGate Therapy for Freezing of Gait in PD
A study testing CereGate Software; BSN cDBS Programmer; BSN Burst Programmer in people with Parkinson Disease and Freezing of Gait, run by CereGate Inc. at 7 sites in United States.
Trial summary
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- What is being tested?
- CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Apr 2022to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs.
- Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
- DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
Who cannot join
- Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent before any study-specific tests or procedures are performed.
- Participant is unwilling or unable to comply with visit schedule and study related procedures.
- Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
- Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
- Participant is less than 21 years of age or older than 80 years of age.
- Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator.
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- Participant has a terminal illness with life expectancy of < 1 year.
- Participant has history of recurrent or unprovoked seizures.
- Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
- Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds /ON-DBS at the time of enrollment.
- Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visual or anatomical abnormality that affects their walking.
- Participant has disabling dyskinesias.
- Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS).
- Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
- Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Drew Kern, MD, 303-724-4172, drew.kern@cuanschutz.edu
Drew Kern, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Neil Shetty, MD, 312-695-7950, Neil.shetty@nm.org
Neil Shetty, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Ihtsham Haq, MD, 305-243-6732, ihaq@med.miami.edu
Lissette Perez, 305-243-2172, lperez4@miami.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Travis J Hassell, M.D., 615-936-2025, travis.j.hassell@vumc.org
Jackie Harris, RMA, CTRC III, 615-936-3833, jacqueline.c.harris@vumc.org
- Recruiting
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California, 94063
Elena Call, MD, 650-464-6321, elena.call@kp.org
Elena Call, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Sarah Simon, 206-221-2132, ssimon3@uw.edu
Yi-Han (Anny) Lin, MD
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27157
Tonya Woosley, CRC, 336-716-9520, twoosley@wakehealth.edu
Deepal Shah-Zamora, MD
About this study
Official title: A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Read the detailed description
This is a multi-center, controlled, study in which participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System will be assessed prior to initiation of CereGate (CG) therapy, and during CereGate therapy. No randomization will occur in this study.
Participants will complete a total of five study visits (2 Screening Visits, Initiation Visit, day 60 follow-up and day 61 follow-up). The expected duration of participation in the clinical study is up to 104 days for each subject.
Up to 41 participants diagnosed with PD previously implanted with a compatible STN-DBS System will be enrolled at up to eight (8) sites in the United States. A maximum of 15 subjects may be enrolled at any site.
More information about the study can be found at www.fog-study.com.
- Conditions
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Being tested
- CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
- Keywords
- Parkinson Disease, Parkinson's Disease, Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease, Gait Disorders, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor, Motor Disorder, Gait Impairment
- Medical subject headings
- Parkinson Disease, Mobility Limitation, Gait Disorders, Neurologic, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereGate Software; BSN cDBS Programmer; BSN Burst ProgrammerDevice
CereGate's objective is to, with a single DBS system implanted in the standard STN location for PD:
(i) deliver conventional tonic DBS stimulation of STN-to mitigate dopamine-responsive symptoms; and concurrently (ii) deliver bursting DBS-induced "cueing" stimulation-to mitigate FOG.
The sole function of CereGate Software is to guide the clinician through a systematic investigation of the stimulation parameter space to thereby configure / tune CereGate Therapy for each participant. CereGate Software proposes parameters for the clinician to evaluate and assists in documenting the response. It does not send commands to, nor control the output of, the DBS System.
| Study group | Role | What they receive |
|---|---|---|
| PD Patients treated with CereGate Software | Experimental | This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand. Receives: Device: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Objective
The primary objective of this study is to determine whether adjunctive use of CereGate therapy reduces Freezing of Gait in participants diagnosed with Parkinson's Disease in the ON-MEDS/ON-DBS state. The primary efficacy endpoint for this study is the mean percent change in excess arrhythmicity during Turning and Barriers Course Figures of 8 (TBC-F8) while ON-med/ON-DBS, pre-CG therapy to post-CG Therapy follow-up. The Opal wearable inertial measurement sensor (APDM Inc., Portland, OR) will be used to capture kinemetric data, from which the arrhythmicity will be extracted. Excess arrhythmicity will be calculated by subtracting the "normal" arrhythmicity (during TBC-F8 in age-matched controls).
Measured: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
Secondary outcomes (1)
Secondary Efficacy Endpoint
The secondary objective of this study is to determine whether adjunctive use of CereGate therapy reduces FOG in participants diagnosed with PD as measured by mean percent change in excess arrhythmicity in the OFF-med/ON-DBS state.
Measured: Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start18 Apr 2022
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CereGate Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Kmiecik, Study chair, CereGate Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292794
- Sponsor's protocol ID
- CG-001
- Status last verified
- May 2026
- First submitted
- 23 Feb 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05292794
- Acronym / sponsor ID
- CG-001
- Conditions
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Keywords
- Parkinson Disease, Parkinson's Disease, Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease, Gait Disorders, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor, Motor Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- CereGate Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Mar 2022 (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.
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Detailed description
This is a multi-center, controlled, study in which participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System will be assessed prior to initiation of CereGate (CG) therapy, and during CereGate therapy. No randomization will occur in this study.
Participants will complete a total of five study visits (2 Screening Visits, Initiation Visit, day 60 follow-up and day 61 follow-up). The expected duration of participation in the clinical study is up to 104 days for each subject.
Up to 41 participants diagnosed with PD previously implanted with a compatible STN-DBS System will be enrolled at up to eight (8) sites in the United States. A maximum of 15 subjects may be enrolled at any site.
More information about the study can be found at www.fog-study.com.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Patients treated with CereGate Software | Experimental | Device: CereGate Software; BSN cDBS Programmer; BSN Burst ProgrammerThis singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs.
- Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
- DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
Key exclusion criteria (15 listed)
- Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent before any study-specific tests or procedures are performed.
- Participant is unwilling or unable to comply with visit schedule and study related procedures.
- Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
- Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
- Participant is less than 21 years of age or older than 80 years of age.
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 |
|---|---|---|
| CereGate Software; BSN cDBS Programmer; BSN Burst ProgrammerCereGate's objective is to, with a single DBS system implanted in the standard STN location for PD: (i) deliver conventional tonic DBS stimulation of STN-to mitigate dopamine-responsive symptoms; and concurrently (ii) deliver bursting DBS-induced "cueing" stimulation-to mitigate FOG. The sole function of CereGate Software is to guide the clinician through a systematic investigation of the stimulation parameter space to thereby configure / tune CereGate Therapy for each participant. CereGate Software proposes parameters for the clinician to evaluate and assists in documenting the response. It does not send commands to, nor control the output of, the DBS System. | Device | PD Patients treated with CereGate Software |
Primary outcome
Primary Efficacy Objective
Time frame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
The primary objective of this study is to determine whether adjunctive use of CereGate therapy reduces Freezing of Gait in participants diagnosed with Parkinson's Disease in the ON-MEDS/ON-DBS state. The primary efficacy endpoint for this study is the mean percent change in excess arrhythmicity during Turning and Barriers Course Figures of 8 (TBC-F8) while ON-med/ON-DBS, pre-CG therapy to post-CG Therapy follow-up. The Opal wearable inertial measurement sensor (APDM Inc., Portland, OR) will be used to capture kinemetric data, from which the arrhythmicity will be extracted. Excess arrhythmicity will be calculated by subtracting the "normal" arrhythmicity (during TBC-F8 in age-matched controls).
1 secondary outcome
Secondary Efficacy Endpoint
Time frame: Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
Kathleen Kmiecik study chair
CereGate Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CereGate Software; BSN cDBS Programmer; BSN Burst Programmer in people with Parkinson Disease and Freezing of Gait, run by CereGate Inc. at 7 sites in United States.
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 15 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Kmiecik (330-241-9098, kathleen@ceregate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Objective (time frame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)). 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 28 May 2026.