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Use of CereGate Therapy for Freezing of Gait in PD

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits, 2 visits
  • Time periods mentioned: 104 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CereGate therapy can reduce freezing of gait in people with Parkinson’s disease. Freezing of gait means feeling stuck when trying to walk. The study is for people who already have a certain deep brain stimulation (DBS) device and take Parkinson’s medicine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an implanted DBS system that sends electrical signals to a brain area called the STN. It must use a Boston Scientific Gevia or Genus R16 pulse generator with FDA-approved wires or extensions for that device.
  • Take carbidopa/levodopa, a dopamine agonist, or both. These are Parkinson’s medicines, and a movement specialist must decide that the doses are best for you.
  • Have DBS settings adjusted for the best results, with recorded improvement in movement symptoms.

Who can't join

  • Are younger than 21 or older than 80; cannot understand the study or give written consent; or cannot or will not follow the visit schedule and study steps.
  • Have changed Parkinson’s medicines or DBS settings within 28 days before starting CereGate therapy.
  • Are breastfeeding, or can become pregnant and have a positive urine pregnancy test or are not using birth control the study doctor considers adequate.
  • Have a terminal illness with less than 1 year to live, a history of repeated seizures or seizures without a clear cause, or a current diagnosis of drug or alcohol abuse.
  • Have very advanced Parkinson’s disease and cannot walk even with medicine and DBS, or need a walking aid for the study walking test while off medicine and using DBS.
  • Have another condition that affects walking or could affect the study, such as muscle, bone, nerve, vision, or body-structure problems or a hip or knee replacement; or have disabling unwanted movements.
  • Have ever attempted suicide or have current suicidal thoughts that meet the study’s screening rules.
  • Do not feel distinct sensations on both sides during the STN stimulation test, or have less than 8% unevenness in walking rhythm on the study’s turning and barrier test before CereGate therapy, while using medicine and DBS.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (7)

CA

CO

FL

IL

NC

TN

WA