Now enrolling

For people with Parkinson’s with a Deep Brain Stimulation (DBS) System

Clinical study evaluating an investigational device for freezing of gait (FOG)

There are no changes to your medications, no surgeries and no invasive procedures.

Now enrolling

For people with Parkinson’s with a Deep Brain Stimulation (DBS) System

Clinical study evaluating an investigational device for freezing of gait (FOG)

There are no changes to your medications, no surgeries and no invasive procedures.

Overseen by an Independent Institutional Review Board (IRB)
Independent panels of experts review and monitor this study to protect the rights, safety, and welfare of participants, ensuring the research is ethical and in compliance with regulations.

Registered on ClinicalTrials.gov
This study is listed in the official NIH National Library of Medicine registry. You can view the public study details at any time here.

Overseen by an Independent Institutional Review Board (IRB)
Independent panels of experts review and monitor this study to protect the rights, safety, and welfare of participants, ensuring the research is ethical and in compliance with regulations.

Registered on ClinicalTrials.gov
This study is listed in the official NIH National Library of Medicine registry. You can view the public study details at any time here.

Do you struggle with
freezing of gait?

Do you struggle with
freezing of gait?

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 clinical research study to evaluate CereGate Therapy for freezing of gait.

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 clinical research study to evaluate CereGate Therapy for freezing of gait.

Research moves us forward

CereGate Therapy

CereGate Therapy involves adding an additional program to your existing DBS system for you to use while walking. This program is intended to create rhythmic sensation to prompt, or “cue” you to step while walking. The aim is to explore whether this could function as an internal cue—similar to external cues like a metronome—to determine whether it helps reduce freezing of gait.

Research moves us forward

CereGate Therapy

CereGate Therapy involves adding an additional program to your existing DBS system for you to use while walking. This program is intended to create rhythmic sensation to prompt, or “cue” you to step while walking. The aim is to explore whether this could function as an internal cue—similar to external cues like a metronome—to determine whether it helps reduce freezing of gait.

What’s involved
(at a glance)

  • No surgery

  • No new medications

  • No changes to your existing medications

  • No imaging procedures

  • No cost for study-related care
  • Compensation for attending 5 clinic visits over 90–125 days

What’s involved
(at a glance)

  • No surgery

  • No new medications

  • No changes to your existing medications

  • No imaging procedures

  • No cost for study-related care
  • Compensation for attending 5 clinic visits over 90–125 days

About CereGate

CereGate’s mission is to empower lives with self-determination, by harnessing advanced neurotechnology to restore and even reimagine human senses through minimally invasive solutions. Our freezing of gait project began over five years ago, and after showing promising results in small studies, is now being tested in this larger study.

About CereGate

CereGate’s mission is to empower lives with self-determination, by harnessing advanced neurotechnology to restore and even reimagine human senses through minimally invasive solutions. Our freezing of gait project began over five years ago, and after showing promising results in small studies, is now being tested in this larger study.

“Our technology offers the possibility of helping people with Parkinson’s maintain their independence a little longer. Your participation in this study helps us answer important questions such as: does it work, and how effective is it?“

Brian Blischak

President CereGate Inc.

“Our technology offers the possibility of helping people with Parkinson’s maintain their independence a little longer. Your participation in this study helps us answer important questions such as: does it work, and how effective is it?”

Brian Blischak

President CereGate Inc.

If everyday steps matter to you, consider taking the next step with us.

No one understands the challenge of freezing of gait better than you do. That’s exactly why your contribution to this research is so important. Your participation in our study could make a real difference in improving treatment for many people living with Parkinson’s.

If everyday steps matter to you, consider taking the next step with us.

No one understands the challenge of freezing of gait better than you do. That’s exactly why your contribution to this research is so important. Your participation in our study could make a real difference in improving treatment for many people living with Parkinson’s.

How Does the Study Work?
A Look Behind the Scenes

We understand that joining a clinical study can bring up a lot of questions. That’s why we want to walk you through every step—openly and clearly. You might be surprised by how simple and straightforward it really is.

The Scientific Idea: A Rhythm from Within

How Does the Study Work?
A Look Behind the Scenes

We understand that joining a clinical study can bring up a lot of questions. That’s why we want to walk you through every step—openly and clearly. You might be surprised by how simple and straightforward it really is.

The Scientific Idea: A Rhythm from Within

The conventional approach:
EXTERNAL rhythmic cues

Many people with Parkinson’s already use external tools to help mitigate freezing of gait. A metronome that sets a steady beat, or a laser light on a cane that projects a line to step over—these are examples of “external rhythmic cues.” They can help the brain trigger the next step.

CereGate’s novel approach:
INTERNAL rhythmic cues

CereGate therapy builds on this same principle but brings the rhythmic cues inside your body. Using your existing DBS system, a gentle, rhythmic tingling sensation is created—serving as an “internal cue” intended to help get you started and keep you moving.

The conventional approach:
EXTERNAL rhythmic cues

Many people with Parkinson’s already use external tools to help mitigate freezing of gait. A metronome that sets a steady beat, or a laser light on a cane that projects a line to step over—these are examples of “external rhythmic cues.” They can help the brain trigger the next step.

CereGate’s novel approach:
INTERNAL rhythmic cues

CereGate therapy builds on this same principle but brings the rhythmic cues inside your body. Using your existing DBS system, a gentle, rhythmic tingling sensation is created—serving as an “internal cue” intended to help get you started and keep you moving.

What you can expect

What you can expect

Phase 1

Screening (2 Visits)

• Informed Consent:
The study team will give you an informed consent document that explains the study’s purpose, procedures, potential risks and benefits, and your rights. They will review the document with you, answer all your questions, and ask you to sign the document.
• Eligibility Check and Baseline Data:
The study team will ask you some questions, and ask you to perform some tasks to evaluate your Parkinson’s and freezing. The purpose is to confirm that you meet all the criteria to join the study, and to collect baseline data. You will abstain from taking your Parkinson’s medications the morning of the second visit.

Phase 1

Screening (2 Visits)

• Informed Consent:
The study team will give you an informed consent document that explains the study’s purpose, procedures, potential risks and benefits, and your rights. They will review the document with you, answer all your questions, and ask you to sign the document.
• Eligibility Check and Baseline Data:
The study team will ask you some questions, and ask you to perform some tasks to evaluate your Parkinson’s and freezing. The purpose is to confirm that you meet all the criteria to join the study, and to collect baseline data. You will abstain from taking your Parkinson’s medications the morning of the second visit.

Phase 2

Starting CereGate Therapy

• More Baseline Data:
Similar to the second study visit, you will be asked some questions, and asked to perform some tasks to evaluate your Parkinson’s and freezing.
• Starting CereGate Therapy:
Your DBS system will be reprogrammed to add an extra program. You will be taught how and when to use the extra program.

Phase 2

Starting CereGate Therapy

• More Baseline Data:
Similar to the second study visit, you will be asked some questions, and asked to perform some tasks to evaluate your Parkinson’s and freezing.
• Starting CereGate Therapy:
Your DBS system will be reprogrammed to add an extra program. You will be taught how and when to use the extra program.

Phase 3

At-Home Use (Approximately 60 days)

• Real-world Use:
You will use CereGate therapy as-needed in your daily activities. One day each week you will complete a diary to document any freezing or falls that occurred on that day.
• On-going support:
Every two weeks you’ll have a 15-20 minute phone call with the study team. You’ll also have a phone number that you can use to call them 24/7 if you have any problems.

Phase 3

At-Home Use (Approximately 60 days)

• Real-world Use:
You will use CereGate therapy as-needed in your daily activities. One day each week you will complete a diary to document any freezing or falls that occurred on that day.
• On-going support:
Every two weeks you’ll have a 15-20 minute phone call with the study team. You’ll also have a phone number that you can use to call them 24/7 if you have any problems.

Phase 4

Final Assessment (2 Visits)

• Wrap up visits:
The study team will complete the data collection by asking you the same types of questions asked in the first 3 visits (plus a few more), and asking you to perform the same tasks to evaluate your Parkinson’s and freezing.

Phase 4

Final Assessment (2 Visits)

• Wrap up visits:
The study team will complete the data collection by asking you the same types of questions asked in the first 3 visits (plus a few more), and asking you to perform the same tasks to evaluate your Parkinson’s and freezing.

How do we measure progress?

How do we measure progress?

Freezing of gait often appears suddenly and unpredictably—making it hard to measure. That’s why we combine your personal feedback with clinical observations and electronic measurements.

Everything takes place in a safe, professional environment. The study team will guide you through completing various questions and a walking task that mimics real-life situations. This data helps us to objectively evaluate your Parkinson’s and your freezing with and without CereGate Therapy and medications.

This is what we do:

  • Expert observation: Doctors and researchers observe and assess your Parkinson’s using standard criteria.
  • Questionnaires: You complete some questionnaires.
  • Video recordings: Walking sessions are recorded to allow careful interpretation of the data.
  • Small motion sensors: Lightweight wearable sensors—similar to a FitBit™—are used record your walking in detail.

These tasks are not physically demanding and are used purely for scientific data collection. Your safety is our top priority.

Freezing of gait often appears suddenly and unpredictably—making it hard to measure. That’s why we combine your personal feedback with clinical observations.

Everything takes place in a safe, professional environment. The study team will guide you through completing various questions and a walking task that mimics real-life situations. This data helps us to objectively evaluate your Parkinson’s and your freezing with and without CereGate Therapy and medications.

This is what we do:

  • Expert observation: Doctors and researchers observe and assess your Parkinson’s using standard criteria.
  • Questionnaires: You complete some questionnaires.
  • Video recordings: Walking sessions are recorded to allow careful interpretation of the data.
  • Small motion sensors: Lightweight wearable sensors—similar to a FitBit™—are used record your walking in detail.

These tasks are not physically demanding and are used purely for scientific data collection. Your safety is our top priority.

Find a Study Center Near You:
This study is being conducted at carefully selected, leading clinics across the U.S.

We understand that travel can be a challenge—for you and your loved ones. Use the map to see if there’s a location within reach. Even if distance feels like a concern, we encourage you to complete the eligibility questionnaire. There may be support options available to help with travel.

Find a Study Center Near You:
This study is being conducted at carefully selected, leading clinics across the U.S.

We understand that travel can be a challenge—for you and your loved ones. Use the map to see if there’s a location within reach. Even if distance feels like a concern, we encourage you to complete the eligibility questionnaire. There may be support options available to help with travel.

1 Colorado

Denver

2 Florida

Miami

3 Illinois

Chicago

4 Washington

Seattle

1 Colorado

Denver

2 Florida

Miami

3 Illinois

Chicago

4 Washington

Seattle

For Care Partners and Loved Ones

We know your role goes far beyond just providing support. You are often the steady hand, the most trusted advisor, and the driving force when it comes to exploring new options. Your confidence and trust are essential to us, and we want to answer your most important questions directly.

For Care Partners and Loved Ones

We know your role goes far beyond just providing support. You are often the steady hand, the most trusted advisor, and the driving force when it comes to exploring new options. Your confidence and trust are essential to us, and we want to answer your most important questions directly.

Your primary concern is understandably the safety and well-being of your family member. Let us address that head-on: This study was designed to avoid disrupting their established and trusted treatment plan.

No changes to their current therapy–and nothing taken away: There are no new drugs, no surgery, no changes to their current medication regimen. They will continue to have the ability to use their existing DBS settings.The familiar treatment plan that provides them with stability will remain completely unchanged.

They will be given an additional DBS program to use when walking.  If they have any problems with this program, then they can use their existing DBS program, and avoid using the additional program until the clinical study team can adjust it.

Each office visit typically takes 3-4 hours. We recognize that every appointment requires a significant effort from you—from transportation to the time you invest. Please know how much we value that.

Support for travel: We understand that logistics can be a challenge. For this reason, assistance with travel expenses to the study center for study visits is available. Please feel free to discuss this with the study team.

By lending your support, you are not only enabling your loved one to make an active contribution to the fight against Parkinson’s, but also becoming part of important research that has the potential to meaningfully reduce freezing of gait for countless people in the future. It is a proactive step that offers hope—not for a cure—but for reducing some of the burden of living with Parkinson’s.

Your support makes all the difference. Thank you for your trust.

Your primary concern is understandably the safety and well-being of your family member. Let us address that head-on: This study was designed to avoid disrupting their established and trusted treatment plan.

No Changes to their current therapy–and nothing taken away: There are no new drugs, no surgery, no changes to their current medication regimen. They will continue to have the ability to use their existing DBS settings.The familiar treatment plan that provides them with stability will remain completely unchanged.

They will be given an additional DBS program to use when walking. If they have any problems with this program, then they can use their existing DBS program, and avoid using the additional program until the clinical study team can adjust it.

Each office visit typically takes 3-4 hours. We recognize that every appointment requires a significant effort from you—from transportation to the time you invest. Please know how much we value that.

Support for travel: We understand that logistics can be a challenge. For this reason, assistance with travel expenses to the study center for study visits is available. Please feel free to discuss this with the study team.

By lending your support, you are not only enabling your loved one to make an active contribution to the fight against Parkinson’s, but also becoming part of important research that has the potential to meaningfully reduce freezing of gait for countless people in the future. It is a proactive step that offers hope—not for a cure—but for reducing some of the burden of living with Parkinson’s.

Your support makes all the difference. Thank you for your trust.

Frequently Asked Questions

Frequently Asked Questions

About the Study and the Therapy

The goal is to collect data to determine whether or not a new, investigational therapy can help some people with Parkinson’s-related freezing of gait. Freezing of gait is a very challenging symptom with few effective treatment options, and your contribution helps us better understand this phenomenon.

This study is sponsored by CereGate, Inc., a company dedicated to developing new therapeutic options for people living with neurological disorders. The research is being conducted at leading, specialized clinical centers across the United States by experienced movement disorder neurologists and their research teams who are experts in Parkinson’s disease.

No, this therapy will not do anything to change the course of your Parkinson’s disease. The intent of the therapy is solely to attempt to mitigate (reduce in frequency or severity) freezing of gait symptoms.

The therapy uses your existing implanted DBS system to create a rhythmic, tingling sensation in your body. This rhythmic sensation is intended to act as an “internal cue”—much like a metronome—to help you keep moving, and/or unfreeze you if you freeze. No new surgery or new device is required.

About the Study and the Therapy

The goal is to collect data to determine whether or not a new, investigational therapy can help some people with Parkinson’s-related freezing of gait. Freezing of gait is a very challenging symptom with few effective treatment options, and your contribution helps us better understand this phenomenon.

This study is sponsored by CereGate, Inc., a company dedicated to developing new therapeutic options for people living with neurological disorders. The research is being conducted at leading, specialized clinical centers across the United States by experienced movement disorder neurologists and their research teams who are experts in Parkinson’s disease.

No, this therapy will not do anything to change the course of your Parkinson’s disease. The intent of the therapy is solely to attempt to mitigate (reduce in frequency or severity) freezing of gait symptoms.

The therapy uses your existing implanted DBS system to create a rhythmic, tingling sensation in your body. This rhythmic sensation is intended to act as an “internal cue”—much like a metronome—to help you keep moving, and/or unfreeze you if you freeze. No new surgery or new device is required.

Participation and Eligibility

We are looking for volunteers who meet the following criteria:

  • A physician’s diagnosis of Parkinson’s disease and freezing of gait.
  • Currently taking Parkinson’s medication such as levodopa/carbidopa.
  • Have an implanted deep brain stimulation (DBS) system.
  • Are under 80 years of age.

No. You will be asked to continue to take all your current medications and to make no changes to your medications for the duration of the study. The only exception is that, for two of the study visits you will take your medications the night before, and then skip your medication in the morning until after the study doctor can see you.

That is not a problem. Please fill out the questionnaire to the best of your ability. If you appear to be a potential match, a study representative will contact you and help clarify the necessary information.

Participation and Eligibility

We are looking for volunteers who meet the following criteria:

  • A physician’s diagnosis of Parkinson’s disease and freezing of gait.
  • Currently taking Parkinson’s medication such as levodopa/carbidopa.
  • Have an implanted deep brain stimulation (DBS) system.
  • Are under 80 years of age.

No. You will be asked to continue to take all your current medications and to make no changes to your medications for the duration of the study. The only exception is that, for two of the study visits you will take your medications the night before, and then skip your medication in the morning until after the study doctor can see you.

That is not a problem. Please fill out the questionnaire to the best of your ability. If you appear to be a potential match, a study representative will contact you and help clarify the necessary information.

Process and Commitment

Participating in the study requires:

  • 5 clinic visits over a period of 90 to 125 days.
  • Keeping a short diary one day each week.
  • A brief phone call (about 15-20 minutes) with the study team every two weeks.

We understand that transportation can be a significant concern. Support for travel-related expenses is available to help ease the burden on you and your family. We recommend you complete the initial questionnaire, and if you appear to be eligible to participate, then a study coordinator can discuss the specific travel support options.

No. The study is completely non-invasive. There is no surgery, no new medications, no changes to your medications, and no imaging procedures like an MRI or CT scan.

Each study visit involves completing some questionnaires and some standard neurological assessments that your doctor has probably previously performed on you, as well as a walking test to assess your freezing. At visit #3, your DBS system will be reprogrammed to add another program for you to use when walking.

Process and Commitment

Participating in the study requires:

  • 5 clinic visits over a period of 90 to 125 days.
  • Keeping a short diary one day each week.
  • A brief phone call (about 15-20 minutes) with the study team every two weeks.

We understand that transportation can be a significant concern. Support for travel-related expenses is available to help ease the burden on you and your family. We recommend you complete the initial questionnaire, and if you appear to be eligible to participate, then a study coordinator can discuss the specific travel support options.

No. The study is completely non-invasive. There is no surgery, no new medications, no changes to your medications, and no imaging procedures like an MRI or CT scan.

Each study visit involves completing some questionnaires and some standard neurological assessments that your doctor has probably previously performed on you, as well as a walking test to assess your freezing. At visit #3, your DBS system will be reprogrammed to add another program for you to use when walking.

Costs, Risks, and Other Information

No, there is no cost to you. All study-related procedures are covered by the study sponsor.

Yes. You will receive compensation for your time attending the 5 in-clinic study visits and biweekly phone calls, and for completing the weekly diary.

As with any study, there are potential risks. Before you agree to participate, you will have a detailed discussion with a member of the clinical study team who will give you a document called an “informed consent document” that explains all known risks, and give you an opportunity to ask all your questions. You will only be asked to sign the consent form after all of your questions have been answered.

Your participation is completely voluntary. You have the right to withdraw from the study at any time—for any reason or no reason—without it affecting your current or future medical care in any way.

Absolutely. Your privacy is a top priority. All information you provide is handled with the strictest confidentiality. The informed consent document provides a detailed description of these safeguards.

That is very understandable and important. The support of family and care partners is crucial. We encourage you to include your loved ones in the decision-making process, and they are welcome to join you for the informational sessions and some parts of the study visits. (Ask the study coordinator for details.) The safety of our participants is our highest priority, a point that is especially important to care partners.

Simply complete the no-obligation “See If You Qualify” questionnaire. If the initial criteria are met, you will be able to speak with a study representative who will discuss further details and answer your questions.

Costs, Risks, and Other Information

No, there is no cost to you. All study-related procedures are covered by the study sponsor.

Yes. You will receive compensation for your time attending the 5 in-clinic study visits and biweekly phone calls, and for completing the weekly diary.

As with any study, there are potential risks. Before you agree to participate, you will have a detailed discussion with a member of the clinical study team who will give you a document called an “informed consent document” that explains all known risks, and give you an opportunity to ask all your questions. You will only be asked to sign the consent form after all of your questions have been answered.

Your participation is completely voluntary. You have the right to withdraw from the study at any time—for any reason or no reason—without it affecting your current or future medical care in any way.

Absolutely. Your privacy is a top priority. All information you provide is handled with the strictest confidentiality. The informed consent document provides a detailed description of these safeguards.

That is very understandable and important. The support of family and care partners is crucial. We encourage you to include your loved ones in the decision-making process, and they are welcome to join you for the informational sessions and some parts of the study visits. (Ask the study coordinator for details.) The safety of our participants is our highest priority, a point that is especially important to care partners.

Simply complete the no-obligation “See If You Qualify” questionnaire. If the initial criteria are met, you will be able to speak with a study representative who will discuss further details and answer your questions.

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 (24/7), or to call them back at a more convenient time (24/7).​

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 (24/7), or to call them back at a more convenient time (24/7).​

Do you currently have:

1. a confirmed diagnosis of Parkinson’s disease?

2. a clinical diagnosis of Freezing of Gait?

3. an implanted Deep Brain Stimulation (DBS) system?

Great! You have passed the initial step.

Please select the study site that suits you best. You will then be able to speak to a study call center representative who will ask you some more detailed questions, and give you the opportunity to ask your questions.

Study Site

Unfortunately, you don't qualify.

This study is only for people with an implanted Deep Brain Stimulation (DBS) system with diagnoses of Parkinson’s disease and freezing of gait.

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