CereGate Therapy for Freezing of Gait in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Kathleen Kmiecik
• Email: kathleen@ceregate.com
• Phone: 330-241-9098

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How physical activity might help people with Parkinson’s disease who have DBS-STN implants

  This study tests whether adding regular physical activity can help people with Parkinson’s who have DBS-STN stimulation by trying a structured physiotherapy approach alongside standard care.

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• Decoding brain signals and DBS settings for freezing of gait in Parkinson’s

  This study tests how brain activity and different DBS settings affect freezing of gait and balance in people with Parkinson’s who already have a Medtronic Percept DBS device.

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• Patterned deep brain stimulation delivered at home for Parkinson's

  This study will test whether three types of patterned deep brain stimulation can be used safely and comfortably at home in people with Parkinson's who already have stable bilateral STN or GPi Boston Scientific DBS systems.

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• Mediterranean diet for managing weight and body composition after bilateral subthalamic nucleus deep brain stimulation in Parkinson's disease

  It will see if following a Mediterranean diet for three months after bilateral subthalamic nucleus deep brain stimulation helps adults with Parkinson's control weight and improve body composition.

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• Frequency-specific stimulation of subthalamic nucleus subregions to improve inhibitory control in Parkinson's disease

  This tests whether stimulating different parts of the subthalamic nucleus at low (5 Hz) or high (130 Hz) frequencies can improve inhibitory control in people with Parkinson's disease who have deep brain stimulation.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07022522

• How deep brain stimulation affects thinking and memory in Parkinson's

  This project will use MRI scans to see if subthalamic nucleus deep brain stimulation (DBS) changes brain networks and relates to thinking or memory declines in people with Parkinson's disease who already have DBS implants.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT06960096

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.