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

Purpose

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

Detailed Description

This is a multi-center, controlled, study in which participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System will be assessed prior to initiation of CereGate (CG) therapy, and during CereGate therapy. No randomization will occur in this study. Participants will complete a total of five study visits (2 Screening Visits, Initiation Visit, day 60 follow-up and day 61 follow-up). The expected duration of participation in the clinical study is up to 104 days for each subject. Up to 41 participants diagnosed with PD previously implanted with a compatible STN-DBS System will be enrolled at up to five (5) sites in the United States. A maximum of 15 subjects may be enrolled at any site.

Eligibility Criteria

Inclusion Criteria

Participant has implanted Boston Scientific Gevia STN-DBS system

Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist

DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS

Exclusion Criteria

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

Participant is unwilling or unable to comply with visit schedule and study related procedures

Participant's medication regimen has not been stable for at least 28 days prior to CG initiation

Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation

Participant is less than 21 years of age or older than 75 years of age

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

Participant has a terminal illness with life expectancy of \< 1 year.

Participant has history of recurrent or unprovoked seizures.

Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.

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.

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.

Participant has disabling dyskinesias.

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).

Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).

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). Please contact study team for additional exclusion criteria

Keywords and/or Specific Medical Conditions

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

CG-001

Movement Disorders

Nervous System Diseases

Neurodegenerative Diseases

Parkinson Disease

Parkinsonian Disorders

Synucleinopathies

Neurology (Neurological Disorders)

Sponsors

CereGate Inc.