Freezing of Gait for Parkinson's Disease

Overseen By Sommer Amundsen-Huffmaster, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Dementia, Alzheimer's, Seizures, Musculoskeletal, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the causes and signs of freezing of gait (FOG) in people with Parkinson's disease (PD). The researchers will use a Medtronic Percept™ deep brain stimulation system to examine brain activity in individuals with Parkinson's, both with and without FOG, through various movement tasks. Participants can join one or more of the three experiments, which involve tasks like starting to walk, navigating a course, or moving wrists and feet quickly. Suitable candidates for the trial include those with Parkinson's who can walk without a cane for at least 50 meters and have the Medtronic Percept device implanted. As an unphased trial, this study offers a unique opportunity to contribute to understanding Parkinson's disease and potentially improve future treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for use in Parkinson's disease patients?

Research has shown that the Medtronic Percept™ deep brain stimulation (DBS) system is safe for people. The FDA has approved it, indicating it passed strict safety tests for treating Parkinson's disease. Studies have found that patients tolerate this device well, with no new safety issues compared to other DBS systems.

The device is also MR Conditional, meaning it can be safely used during MRI scans if certain guidelines are followed. This ensures patients can still undergo important scans when needed. Overall, the Percept™ DBS system is considered safe for people with Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medtronic Percept™ deep brain stimulation (DBS) system because it offers a unique approach to managing symptoms of Parkinson's disease, especially freezing of gait (FOG). Unlike traditional treatments like medications that primarily address dopamine levels, this DBS system directly targets specific brain areas involved in motor control. The Percept™ system is designed to deliver personalized stimulation, which could lead to more precise symptom management and potentially improve mobility for those with Parkinson’s disease. This tailored approach is what makes it stand out from current options.

What evidence suggests that the Medtronic Percept™ DBS system is effective for freezing of gait in Parkinson's disease?

Research has shown that the Medtronic Percept deep brain stimulation (DBS) system effectively manages Parkinson's disease symptoms. In this trial, participants with Parkinson's disease will receive the Percept DBS system, with one group experiencing freezing of gait (FOG) and another group without FOG. Studies have found that this system can safely and effectively reduce symptoms like FOG, a sudden and temporary inability to move that often affects people with Parkinson's. One study demonstrated that using the Percept DBS system improved walking by focusing on specific brain signals related to movement. The FDA has already approved this system, and it has been successfully used in people with Parkinson's disease. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people aged 21-75 with idiopathic Parkinson's Disease who can walk without help and have a Medtronic Percept TM Device implanted. It's not for those using assistive devices or anyone outside the age range.

Inclusion Criteria

I have an implanted Medtronic Percept TM device.

My neurostimulator has been active for at least 3 months.

I belong to a group that is often overlooked or marginalized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experiment 1

Comparison of LFPs during gait initiation with and without a cue in people with and without FOG

4 weeks

Multiple sessions (in-person)

Experiment 2

Comparison of LFPs during successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG

4 weeks

Multiple sessions (in-person)

Experiment 3

Comparison of LFPs during rapid alternating movements of the wrist and/or foot in people with and without FOG

4 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experiments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Percept™ deep brain stimulation system

Trial Overview The study tests how brain signals during movement differ in Parkinson's patients with and without freezing of gait (FOG). Participants will undergo experiments comparing brain activity in various scenarios, both on and off their usual PD medications or deep brain stimulation.

How Is the Trial Designed?

Group I: Parkinson's disease without freezing of gait Experimental Treatment 2 Interventions

Participants will have a Medtronic Percept DBS device and diagnosis of idiopathic Parkinson's disease (PD) without having freezing of gait (FOG). Participants in this arm will not be tested in experiment #2.

Group II: Parkinson's disease with freezing of gait Experimental Treatment 2 Interventions

Participants will have a Medtronic Percept DBS device, diagnosis of idiopathic Parkinson's disease (PD), and freezing of gait (FOG).

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06848205

NCT06848205 | Percept Transitions in FOG and PD The purpose of this research is to examine the possible causes and signs of freezing of gait (FOG) secondary to Parkinson's disease (PD).

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230310/

Beta Burst-Driven Adaptive Deep Brain Stimulation ... The goal of the current study was to investigate the feasibility, safety, and tolerability of beta burst-driven adaptive DBS (aDBS) for FOG in PD.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The study was a prospective, multicenter, single-arm, aDBS treatment mode blind, randomized crossover trial in subjects with Parkinson's Disease and DBS leads.

5. academic.oup.com academic.oup.com/braincomms/article/7/4/fcaf266/8193943

Beta burst-driven adaptive deep brain stimulation for gait ... The goal of the study was to investigate the feasibility, safety and tolerability of beta burst-driven adaptive deep brain stimulation for gait impairment and ...

6. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-parkinsons-disease/about-dbs-therapy/dbs-products/percept-pc.html

Percept PC - DBS for Parkinson's Disease Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met.

7. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications-safety-warnings.html

Deep Brain Stimulation - Indications, Safety, and Warnings Medtronic DBS systems are MR Conditional which means they are marked to indicate they are safe in the MR environment as long as certain conditions are met.

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-pc-neurostimulator.html

Percept™ PC Neurostimulator The Percept™ PC is a recharge free neurostimulator with sensing, directionality, and advanced programming capabilities for deep brain stimulation (DBS).

9. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2021.1909471

Device profile of the percept PC deep brain stimulation ... There are no new safety concerns regarding the Percept™ PC DBS device, which carries the same contraindications, warnings and precautions as other DBS devices ...