NCT05292794 Use of CereGate Therapy for Freezing of Gait in PD
| NCT ID | NCT05292794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CereGate Inc. |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 41 participants in total. It began in 2022-04-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
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).
Contact & Investigator
Kathleen Kmiecik
STUDY CHAIR
CereGate Inc.
Frequently Asked Questions
Who can join the NCT05292794 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05292794 currently recruiting?
Yes, NCT05292794 is actively recruiting participants. Contact the research team at kathleen@ceregate.com for enrollment information.
Where is the NCT05292794 trial being conducted?
This trial is being conducted at Redwood City, United States, Aurora, United States, Miami, United States, Chicago, United States and 3 additional locations.
Who is sponsoring the NCT05292794 clinical trial?
NCT05292794 is sponsored by CereGate Inc.. The principal investigator is Kathleen Kmiecik at CereGate Inc.. The trial plans to enroll 41 participants.
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