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

Trial Summary

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 data supports the effectiveness of the treatment CereGate Therapy for Freezing of Gait in Parkinson's Disease?

The research suggests that non-drug treatments like action observation and physical therapy can help manage freezing of gait in Parkinson's disease, which is often resistant to medication. This implies that CereGate Therapy, as a non-drug treatment, might also be effective in addressing this issue. ^{1 2 3 4 5}

How is CereGate Therapy different from other treatments for freezing of gait in Parkinson's disease?

CereGate Therapy is unique because it may involve non-pharmacologic strategies like action observation, which can enhance physical training to improve freezing of gait, unlike traditional drug treatments that often have limited effectiveness for this condition. ^{1 2 3 4 6}

What is the purpose of this trial?

A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

Research Team

Brian Blischak

Principal Investigator

CereGate Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Action observation improves freezing of gait in patients with Parkinson's disease. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

A wearable system to assist walking of Parkinson s disease patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A smartphone-based architecture to detect and quantify freezing of gait in Parkinson's disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy for Freezing of Gait and Gait Impairments in Parkinson Disease: A Systematic Review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A 12-year population-based study of freezing of gait in Parkinson's disease. [2015]

6. United States 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. [2022]