CereGate Therapy for Freezing of Gait in 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

This study is testing if CereGate therapy can help people with Parkinson's Disease who have freezing of gait feel more mobile and improve their movement after having deep brain stimulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: CereGate Inc. (Industry-sponsored)
• Locations: 7 sites (Redwood City, California and 6 other locations)
• Trial ID: NCT05292794 on ClinicalTrials.gov

What this trial studies

This multi-center, controlled study evaluates the effectiveness of CereGate therapy in reducing freezing of gait in participants with Parkinson's Disease who have previously undergone subthalamic nucleus deep brain stimulation. Participants will undergo a series of assessments before and during the therapy, with a total of five study visits over a period of up to 104 days. The study aims to gather data on the therapy's impact on motor function and overall mobility in this patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Parkinson's Disease who have an implanted subthalamic nucleus deep brain stimulation system and are on stable medication regimens.

Not a fit: Patients who do not have an implanted STN-DBS system or those whose medication regimens have not been stable for at least 28 days prior to the study will not benefit.

Why it matters

Potential benefit: If successful, this therapy could significantly improve mobility and quality of life for patients experiencing freezing of gait due to Parkinson's Disease.

How similar studies have performed: While there have been studies on deep brain stimulation for Parkinson's Disease, the specific use of CereGate therapy in this context is a novel approach.

Eligibility 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).

Where this trial is running

Redwood City, California and 6 other locations

• Kaiser Permanente, KPNC Comprehensive Movement Disorders Program — Redwood City, California, United States (Recruiting)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Brian Blischak

Conditions Parkinson Disease; Freezing of Gait; Deep Brain Stimulation