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NCT05292794 | RECRUITING | Parkinson Disease

Use of CereGate Therapy for Freezing of Gait in PD
Sponsor:

CereGate Inc.

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

Parkinson Disease

Freezing of Gait

Deep Brain Stimulation

Intervention/treatment

CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 41 participants
Masking : NONE
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 : 2022-04-18
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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.
  • 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 80 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 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).
  • 14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
  • 15. 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).
Use of CereGate Therapy for Freezing of Gait in PD

Location Details

NCT05292794

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

Redwood City, California, United States, 94063

RECRUITING

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

University of Miami

Miami, florida, United States, 33136

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, North Carolina

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Washington

University of Washington

Seattle, Washington, United States, 98195