Percept Transitions in FOG and PD

NCT ID: NCT06848205

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2029-01-01

Brief Summary

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

Detailed Description

The purpose of this research is to examine the underlying pathophysiology and biomarkers of freezing of gait (FOG) and cueing-evoked improvements. This protocol will use the novel (on-label, 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 (PD), 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: In the second experiment, the investigators will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG.

Experiment 3: In the third experiment, the investigators will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG.

Conditions

Freezing of Gait; Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Parkinson's disease with freezing of gait

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

Group Type: EXPERIMENTAL

OFF Parkinson's Medication(s)

Intervention Type: OTHER

Participants will be asked to withhold Parkinson's medications 12 hours prior to their testing visit (if extended-release Parkinson's medications are taken by the participant, they will be asked to withhold these for 24 hours prior to their testing visit).

OFF Deep Brain Stimulation

Intervention Type: OTHER

Participants will have their deep brain stimulation turned off at the beginning of their testing visit.

Parkinson's disease without freezing of gait

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 Type: EXPERIMENTAL

OFF Parkinson's Medication(s)

Intervention Type: OTHER

Participants will be asked to withhold Parkinson's medications 12 hours prior to their testing visit (if extended-release Parkinson's medications are taken by the participant, they will be asked to withhold these for 24 hours prior to their testing visit).

OFF Deep Brain Stimulation

Intervention Type: OTHER

Participants will have their deep brain stimulation turned off at the beginning of their testing visit.

Interventions

OFF Parkinson's Medication(s)

Participants will be asked to withhold Parkinson's medications 12 hours prior to their testing visit (if extended-release Parkinson's medications are taken by the participant, they will be asked to withhold these for 24 hours prior to their testing visit).

Intervention Type: OTHER

OFF Deep Brain Stimulation

Participants will have their deep brain stimulation turned off at the beginning of their testing visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of idiopathic PD.
• Age 21-75 (see Inclusion of Individuals across the Lifespan for justification of age range).
• Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.
• Implanted Medtronic Percept TM Device.
• At least 3 months since the initial activation of the neurostimulator.
• Undervalued, under-represented, or disenfranchised social group may be included.
• Active members of the military (service members), DoD personnel (including civilian employees) may be included.
• Individual or group that is disadvantaged in the distribution of social goods and services such as income, housing, or healthcare may be included.

Exclusion Criteria

• Meet criteria for dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder.
• History of seizures or other significant neurological disorders that may affect participation or performance in the study.
• History of musculoskeletal disorders that significantly affect walking or movement of limb(s) that would affect the participation in the experimental task (Participants will be excluded from that task, but may participate in other tasks, for example, may be excluded from Experiment 1 if the disorder affects walking, but may still participate in Experiment 3).
• History of muscular conditions of the neck and back, including whiplash that would affect walking experiments.
• History of visual and/or vestibular conditions that may affect participation or performance in the study.
• Reduced capacity to consent. This will be assessed using a 2-stage process. Initially, participants will be tested using the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC). If concerns are raised from the UBACC test, the individual will be further tested using the MacArthur Competency Assessment Tool.
• Pregnant people.
• Post-operative complications or adverse effects (e.g. ON stimulation dystonia) that affect patient safety or confound the experiment.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota, Movement Disorders Lab

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Madison Aasen, MS

Role: CONTACT

aasen056@umn.edu

612-505-8325

Sommer Amundsen-Huffmaster, PhD

Role: CONTACT

slamunds@umn.edu

612-301-1297

Facility Contacts

Madison Aasen, MS

Role: primary

aasen056@umn.edu

612-505-8325

Other Identifiers

STUDY00023279

Identifier Type: OTHER

Identifier Source: secondary_id

NEUR-2024-33357

Identifier Type: -

Identifier Source: org_study_id