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

Trial ID: NCT05292794

Interventional - Phase Unknown - Recruiting

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

Conditions

• Parkinson Disease
• Freezing of Gait
• Deep Brain Stimulation

Interventions

• CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

Eligibility

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).

Sponsor

CereGate Inc.

Source: ClinicalTrials.gov

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