Use of CereGate Therapy for Freezing of Gait in PD

Launched by CEREGATE INC. · Mar 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CereGate Therapy, which aims to help people with Parkinson's Disease who experience "freezing of gait." This is when a person suddenly feels unable to move their feet, making it difficult to walk. The trial is looking for participants who have an implanted device for deep brain stimulation (DBS) and are already taking medications for Parkinson's, like carbidopa/levodopa. To be eligible, participants must be between the ages of 21 and 80 and must have stable medication and DBS settings for at least 28 days before starting the study.

If you or a loved one qualifies for this trial, you can expect to participate in a controlled study at multiple locations, which means you might be receiving either the new therapy or a comparison treatment. The goal is to see if CereGate Therapy can improve walking and reduce freezing episodes. It's important to know that participants will need to understand the study's requirements and attend scheduled visits for assessments. If you have any conditions that make walking very difficult or if you're in an advanced stage of Parkinson's, you may not be eligible. This study is currently recruiting participants, so it's a chance to be part of research that could lead to better treatments for freezing of gait in Parkinson's Disease.

Gender

ALL

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).