RECRUITING

Use of CereGate Therapy for Freezing of Gait in PD

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Conditions

Parkinson DiseaseFreezing of GaitDeep Brain Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-04-18
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05292794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
  1. 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. 2. Participant is unwilling or unable to comply with visit schedule and study related procedures.
  3. 3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
  4. 4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
  5. 5. Participant is less than 21 years of age or older than 80 years of age.
  6. 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. 7. Participant has a terminal illness with life expectancy of \< 1 year.
  8. 8. Participant has history of recurrent or unprovoked seizures.
  9. 9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
  10. 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. 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. 12. Participant has disabling dyskinesias.
  13. 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. 14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
  15. 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).

Contacts and Locations

Study Contact

Brian Blischak
CONTACT
972-816-4484
brian@ceregate.com

Principal Investigator

Brian Blischak
STUDY_CHAIR
CereGate Inc.

Study Locations (Sites)

Cedars Sinai Neurology
Los Angeles, California, 90048
United States
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California, 94063
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
University of Miami
Miami, Florida, 33136
United States
Northwestern University
Chicago, Illinois, 60611
United States
Wake Forest University
Winston-Salem, North Carolina, 27157
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: CereGate Inc.

  • Brian Blischak, STUDY_CHAIR, CereGate Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-18
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-04-18
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Freezing of Gait
  • Deep Brain Stimulation