We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of CereGate Therapy for Freezing of Gait in PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05292794
Recruitment Status : Recruiting
First Posted : March 23, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
CereGate Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Freezing of Gait Deep Brain Stimulation Device: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer Not Applicable

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 five (5) sites in the United States. A maximum of 15 subjects may be enrolled at any site.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PD Patients treated with CereGate Software
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.
 Device: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Primary Efficacy Objective [ Time Frame: Pre-CG therapy to post-CG-therapy follow-up Day 61 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 OFF-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 OFF-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).


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint [ Time Frame: Mean percent change in arrhythmicity during TBC-F8 (ON-med/ON-DBS) pre-CG therapy to 60 days post-CG Therapy. ]
    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 ON-med/ON-DBS state.


Other Outcome Measures:
  1. Safety Endpoints [ Time Frame: From 1st Screening Visit through Day 61 (Day 60 ± 8) follow-up visit. ]
    Safety endpoints for this study will include the following by interventional condition (i.e., CereGate therapy ON or OFF): Proportion of participants who experience one or more stimulation-related serious adverse events (SAEs) Proportion of participants who experience any stimulation related adverse event Proportion of participants who experience each unique type of adverse event


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant has implanted Boston Scientific Gevia STN-DBS system
  2. Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
  3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS

Exclusion Criteria:

  1. 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.
  2. Participant is unwilling or unable to comply with visit schedule and study related procedures.
  3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
  4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
  5. Participant is less than 21 years of age or older than 75 years of age.
  6. 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.
  7. Participant has a terminal illness with life expectancy of < 1 year.
  8. Participant has history of recurrent or unprovoked seizures.
  9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
  10. 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.
  11. 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.
  12. Participant has disabling dyskinesias.
  13. Participant has significant cognitive impairment as indicated by MMSE- 2:SV score of ≤27.
  14. 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).
  15. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
  16. Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (OFF Medications/ON DBS /OFF CG).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05292794


Contacts
Layout table for location contacts
Contact: Brian Blischak 972-816-4484 brian@ceregate.com

Locations
Layout table for location information
United States, Arizona
St. Joseph's Hospital and Medical Center: Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Sana Aslam, MD    602-406-5499    sana.aslam@barrowneuro.org   
Contact: Markey Olson    602-406-5944    markey.olson@dignityhealth.org   
United States, California
Cedars Sinai Neurology Recruiting
Los Angeles, California, United States, 90048
Contact: Michele Tagliati, MD    310-248-6938    michele.tagliati@cshs.org   
Contact: Hayley Pomeroy    310-423-1697    hayley.pomeroy@cshs.org   
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program Recruiting
Redwood City, California, United States, 94063
Contact: Elena Call, MD    650-464-6321    elena.call@kp.org   
Stanford University School of Medicine, Center for Academic Medicine Withdrawn
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Drew Kern, MD    303-724-4172    drew.kern@cuanschutz.edu   
Sponsors and Collaborators
CereGate Inc.
Investigators
Layout table for investigator information
Study Chair: Brian Blischak CereGate Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CereGate Inc.
ClinicalTrials.gov Identifier: NCT05292794    
Other Study ID Numbers: CG-001
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases