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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to examine the possible causes and signs of freezing of gait (FOG) secondary to Parkinson's disease (PD). To achieve this, the study will use the novel (on-label and FDA-approved) local field potential (LFP) measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease, with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments: Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG). Experiment 2: The second experiment will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG. Experiment 3: The third experiment will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+