Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT05292794

Use of CereGate Therapy for Freezing of Gait in PD

Led by CereGate Inc. · Updated on 2026-02-27

41

Participants Needed

7

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

CONDITIONS

Official Title

Use of CereGate Therapy for Freezing of Gait in PD

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has an implanted STN-DBS system with Boston Scientific Gevia12 or Genus12 R16 IPG connected to any brand lead or extension approved by the FDA for use with Gevia or Genus IPGs.
  • Participant is receiving treatment with carbidopa/levodopa and/or a dopamine agonist at optimal doses as determined by a movement disorders neurologist.
  • DBS settings are optimized with documented improvement in motor signs (UPDRSIII) from DBS.
Not Eligible

You will not qualify if you...

  • Participant cannot understand the study requirements or is unwilling/unable to provide written informed consent.
  • Participant is unwilling or unable to comply with visit schedule and study procedures.
  • Medication regimen has not been stable for at least 28 days prior to CereGate initiation.
  • DBS stimulation settings have not been stable for at least 28 days prior to CereGate initiation.
  • Participant is younger than 21 years or older than 80 years.
  • Female participants who are breastfeeding or of child-bearing potential with positive pregnancy test or not using adequate contraception.
  • Participant has a terminal illness with life expectancy less than 1 year.
  • History of recurrent or unprovoked seizures.
  • Current diagnosis of drug or alcohol abuse per DSM-5 criteria.
  • Participant is in very advanced stage of Parkinson's disease (Stage 5 on medication and DBS, non-ambulatory, or requires assistive device for walking at enrollment).
  • Conditions affecting walking or study procedures, including musculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or visual/anatomical abnormalities.
  • Disabling dyskinesias.
  • History of suicide attempt or current active suicidal ideation based on Columbia Suicide Severity Rating Scale.
  • Failure of subthalamic nucleus stimulation challenge test at enrollment.
  • Less than 8% arrhythmicity in Turning and Barrier Course Figures of 8 pre-CereGate therapy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

Redwood City, California, United States, 94063

Actively Recruiting

2

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

3

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

4

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

6

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

7

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

Loading map...

Research Team

B

Brian Blischak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here