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.

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.

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.)

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.

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.

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.