BridgeMD
New treatment option for Parkinson Disease
Official title Use of CereGate Therapy for Freezing of Gait in PD
ClinicalTrials.gov ID: NCT05292794
What this study is testing
- What it's testing
- A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- 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...
- Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders...
- DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
You likely can't join if
- Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent...
- 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 80 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...
See the full eligibility criteria
- 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.
- 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
- 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 80 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Winston-Salem, North Carolina, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Chicago, Illinois, United States; Winston-Salem, North Carolina, United States; Nashville, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.