Do you struggle with freezing of gait?
You are not alone.
Would you like to take part in a study of a new investigational treatment for freezing of gait?
We're inviting people with Parkinson's to take part in a study to evaluate the effect of a new investigational device for freezing of gait. All study-related visits and tests will be provided at no cost.
Participants will receive compensation for participating in the study.
☑ No drugs
☑ No surgery
☑ No invasive procedures
☑ No imaging procedures
☑ No cost to participants
☑ 5 clinic visits over 90-125 days
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What is a clinical research study?A clinical research study is a study that helps answer important questions about an investigational drug or device, such as: does it work, or how effective is it compared to another drug/device.
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What happens if I agree to participate in the study?You will be asked to: read and sign an informed consent keep your medications and DBS stimulation the same for the duration of the study keep a diary 1 day each week have a 15-20 minute phone call with the study site every other week attend two screening visits to confirm that you meet all criteria for participating in the study. After confirming that you meet all criteria, you will be asked to: attend an office visit during which your DBS system will be programmed to deliver CereGate Therapy use CereGate Therapy on-demand for approximately 60 days, and then attend two assessment visits.
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How much will it cost me to participate in the study?The study sponsor (CereGate, Inc.) will pay for all study-related costs. (You will continue to be responsible for your non-study related costs of care.)
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How does CereGate Therapy work?Using things outside the body, like a metronome that ticks or a cane with a flashing laser light, can help some people walk better by giving them a steady beat or a line to step over. These are called “external cues” and can make it easier to start walking again when someone freezes. CereGate Therapy is a new way to potentially help with freezing. It uses a special stimulation pattern from your deep brain stimulation (DBS) device to create a rhythmic tingling sensation inside your body while you walk. This tingling acts like an “internal cue” to help you keep moving, kind of like having a helpful reminder inside your body instead of outside. This study will evaluate whether or not these 'internal cues' can reduce freezing of gait in some people with Parkinson's. Participants will have the ability to start and stop using these cues at any time.
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Will I be paid?Yes. You will receive a cash card, and shortly after each study visit you will receive a payment to compensate you for attending the visit. You will also receive an additional payment for attending all visits and completing all study tasks.
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What should I do next?If you have any questions or have decided that you'd like to participate, then complete the See If You Qualify questionnaire. If you meet the preliminary criteria, you will be given the opportunity to speak to a study representative. They will answer many of your questions, and arrange for you to speak with the study coordinator near you.
Let's Go!!
If you think you might like to participate in this freezing of gait study or would like more information, complete the survey below.
If it looks like you may qualify, then you will be given the opportunity to immediately speak with a study representative, or to call them back at a more convenient time.
Please answer the questions as though you are the potential study participant.
1. Have you been diagnosed with Parkinson’s disease by a physician?
2. Have you been diagnosed with freezing of gait by a physician?
3. Are you taking carbidopa/levodopa or a dopamine agonist to manage your Parkinsons symptoms?
Note: Brand names for carbidopa/levodopa combinations include: Sinemet®, Rytary®, and Parcopa®. Dopamine agonists include: pramipexole (Mirapex®), ropinirole (Requip®), rotigotine (Neupro®), apomorphine (Apokyn®), and tavapadon.
4. Are you less than 80 years of age?
5. Do you have an implanted deep brain stimulation (DBS) system?
6. In what part of your brain is (are) the lead(s) implanted?*
Note: If you were able to substantially reduce your Parkinson's medications after getting your DBS system, then select STN.
7. On how many sides of your brain have DBS leads been implanted?*
8. What brand is your deep brain stimulation system?
9. The study involves visiting the study clinic 5 times over a period of 90 - 125 days. Which study site would be most for the potential study participant's?
10. What are your initials?
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