CereGate Therapy for Freezing of Gait in PD

Recruiting at 8 trial locations

Overseen By Mustafa Siddiqui, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CereGate Inc.

Must be taking: Carbidopa/Levodopa, Dopamine agonists

Disqualifiers: Seizures, Drug abuse, Advanced Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 60 days

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called CereGate Therapy to assist people with Parkinson's disease who experience freezing of gait, a condition where they temporarily cannot move their feet forward while walking. The study targets participants who already have a specific brain device (STN-DBS) implanted and are on certain Parkinson's medications. Suitable candidates for the trial include those with Parkinson's who have this device and continue to struggle with sudden stops while walking, despite stable medication and device settings. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research that could enhance mobility for those with Parkinson's.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, your medication regimen must be stable for at least 28 days before starting the trial.

What prior data suggests that CereGate Therapy is safe for reducing freezing of gait in Parkinson's Disease patients?

Research has shown that CereGate Therapy is being studied to assist people with Parkinson's Disease who experience freezing of gait, a difficulty in moving forward while walking. This therapy employs software to enhance movement. Although specific safety data is not yet available, its testing in Parkinson's patients suggests that initial safety assessments might be promising.

CereGate Therapy is used in conjunction with a deep brain stimulation system, an already approved treatment for Parkinson's Disease. Each component of the treatment has undergone safety studies in other contexts. However, as the current study continues, researchers are diligently evaluating its safety and effectiveness for this particular application.

For those considering participation, it may be reassuring to know that these treatments have been studied in different contexts. Nonetheless, discussing any concerns or questions with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CereGate Therapy because it offers a novel approach to managing freezing of gait in Parkinson's Disease (PD) patients. Unlike typical treatments that often involve medication or physical therapy, CereGate Therapy leverages software to interact with an existing deep brain stimulation system. This software-based approach allows for on-demand adjustments, potentially providing more personalized and immediate relief from symptoms. Such innovation could lead to improved mobility and quality of life for PD patients, making it a promising advancement in the field.

What evidence suggests that CereGate Therapy is effective for reducing freezing of gait in Parkinson's Disease?

Research has shown that CereGate Therapy, which participants in this trial will receive, might help reduce freezing of gait (FOG) in people with Parkinson's Disease. FOG occurs when someone suddenly feels as if their feet are stuck to the ground, making movement difficult. Studies suggest that CereGate Therapy uses brain signals and virtual reality to help people walk more smoothly. Early results from studies indicated that this method can improve walking. Although more research is needed, these initial findings are promising for those experiencing FOG. ^{1 2 4 5 6}

Who Is on the Research Team?

Brian Blischak

Principal Investigator

CereGate Inc.

Are You a Good Fit for This Trial?

This trial is for Parkinson's Disease patients with Freezing of Gait who have an implanted Boston Scientific Gevia STN-DBS system and are on stable doses of Parkinson's medications. They must be adults between 21-75 years old, not severely cognitively impaired, and able to follow the study plan.

Inclusion Criteria

You have had deep brain stimulation (DBS) treatment and it has improved your motor skills, as shown in documentation.

I have a Boston Scientific Gevia STN-DBS system implanted.

I am on the best dose of Parkinson's medication as decided by my neurologist.

Exclusion Criteria

I am willing and able to follow the study's schedule and procedures.

I understand the study and can give my consent.

I am in the most advanced stage of Parkinson's disease and need help moving around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Initiation

Participants begin CereGate therapy after assessment

1 day

1 visit (in-person)

Treatment

Participants use the CereGate software for 60 days on demand

60 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-8 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CereGate Therapy

Trial Overview The CereGate Therapy is being tested in this controlled study to see if it can help reduce Freezing of Gait in Parkinson’s patients. It involves using specific software and programmers designed to work with their existing DBS systems.

How Is the Trial Designed?

Group I: PD Patients treated with CereGate Software Experimental Treatment 1 Intervention

This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand.

Who Is Running the Clinical Trial?

CereGate Inc.

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

A wearable device designed to detect freezing of gait (FOG) in patients with advanced Parkinson's disease showed a sensitivity of 73.1% and specificity of 81.6% in identifying FOG events, indicating its potential effectiveness in real-time assistance.

The study involved 10 Parkinson's patients and recorded over eight hours of data, suggesting that the device can provide timely auditory cues to help patients resume walking, which could significantly improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable system to assist walking of Parkinson s disease patients. Bächlin, M., Plotnik, M., Roggen, D., et al.[2022]

In a study involving 20 patients with Parkinson's disease, those who engaged in action observation (watching videos of movements to overcome freezing of gait) showed a significant reduction in FOG episodes at follow-up, compared to those who watched static landscape videos.

Both groups experienced improvements in motor performance and quality of life after physical therapy, but the action observation group had additional benefits, suggesting that combining observation with physical training could enhance rehabilitation for freezing of gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action observation improves freezing of gait in patients with Parkinson's disease. Pelosin, E., Avanzino, L., Bove, M., et al.[2022]

In a study of five Parkinson's disease patients who developed unresponsive freezing of gait (FOG) after deep brain stimulation, intestinal levodopa/carbidopa infusion improved FOG symptoms in 80% of the patients, as measured by the Unified Parkinson's Disease Rating Scale.

The improvement in FOG symptoms was significant, with a reduction of 2 or more points maintained for at least 12 months, suggesting that intestinal levodopa infusion could be an effective long-term treatment option for this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal Levodopa/Carbidopa Infusion as a Therapeutic Option for Unresponsive Freezing of Gait after Deep Brain Stimulation in Parkinson's Disease. González-Herrero, B., Jauma-Classen, S., Gómez-Llopico, R., et al.[2022]

Physical therapy interventions, particularly visual and auditory cueing, treadmill walking, and aquatic obstacle training, have been shown to significantly reduce freezing of gait (FOG) in Parkinson's disease patients, with strong evidence supporting their efficacy.

While these interventions are effective for managing FOG and gait impairments, further research is needed to explore the benefits of other therapies like balance training and tactile cues, as they show potential but lack sufficient evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy for Freezing of Gait and Gait Impairments in Parkinson Disease: A Systematic Review. Rutz, DG., Benninger, DH.[2021]

A smartphone-based system for detecting freezing of gait (FOG) in Parkinson's Disease patients demonstrated high reliability, with the second algorithm achieving a sensitivity of 87.57% and specificity of 94.97% in identifying FOG events during tests with 20 participants.

The study confirmed the effectiveness of the Moore-Bächlin Algorithm and showed that enhancements to the detection system can significantly improve the identification of FOG episodes, which may aid in better treatment assessment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-based architecture to detect and quantify freezing of gait in Parkinson's disease. Capecci, M., Pepa, L., Verdini, F., et al.[2022]

In a 12-year study of 232 Parkinson's disease patients, the prevalence of freezing of gait (FOG) increased from 27% at the start to 63% by the end, indicating that FOG is a common and worsening issue in this population.

Key risk factors for developing FOG included motor fluctuations and higher doses of levodopa, suggesting that both dopaminergic and non-dopaminergic brain pathways may contribute to this disabling symptom.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-year population-based study of freezing of gait in Parkinson's disease. Forsaa, EB., Larsen, JP., Wentzel-Larsen, T., et al.[2015]

Citations

1. um-movement.webflow.io um-movement.webflow.io/studies/ceregate-fog-lights

CereGATE FOG LIGHTS The purpose of the study is to determine whether or not CereGateTherapy can reduce freezing of gait in people with Parkinsons. CereGate therapy uses the Gevia™ ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05292794/use-of-ceregate-therapy-for-freezing-of-gait-in-pd

Use of CereGate Therapy for Freezing of Gait in PD A multi-center, controlled study to evaluate use of CereGate therapy to reduce freezing of gait in participants diagnosed with Parkinson's Disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10696025/

A meta-analysis identifies factors predicting the future ... Freezing of gait (FOG) is a debilitating problem that is common among many, but not all, people with Parkinson's disease (PD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05292794

Use of CereGate Therapy for Freezing of Gait in PD The primary objective of this study is to determine whether adjunctive use of CereGate therapy reduces Freezing of Gait in participants diagnosed with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12251975/

An Experimental Approach for Investigating Freezing of Gait in ... An experimental approach for investigating freezing of gait in Parkinson's disease using virtual reality and neural sensing: a pilot study.

6. um-movement.webflow.io um-movement.webflow.io/research/studies

Studies | University of Miami Movement Disorders Division The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease.