Recruiting

LFP Measurement

Sponsor:

University of Minnesota

Code:

NCT06848205

Conditions

Freezing of Gait

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

OFF Parkinson's Medication(s)

OFF Deep Brain Stimulation

Study Details

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

Conditions

Freezing of Gait

Parkinson Disease

Study ID

NCT06848205

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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).

experimental: 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.

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).

OFF Deep Brain Stimulation

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

Primary outcome measure

  • Quantification of the anticipatory postural adjustments magnitudes (cm) [ Time Frame: During the intervention ]
  • Quantification of the anticipatory postural adjustments duration (sec) [ Time Frame: During the intervention ]
  • Step characteristics of the first two steps, length (cm) [ Time Frame: During the intervention ]
  • Step characteristics of the first two steps, width (cm) [ Time Frame: During the intervention ]
  • Step characteristics of the first two steps, duration (sec) [ Time Frame: During the intervention ]
  • The coherence magnitudes between the cortex and globus pallidus (dB) [ Time Frame: During the intervention ]
  • The coherence magnitudes between the cortex and EMG (dB) [ Time Frame: During the intervention ]
  • The coherence magnitudes between the globus pallidus and EMG (dB) [ Time Frame: During the intervention ]
  • Number of freezing episodes [ Time Frame: During the intervention ]
  • Rapid Alternating Movements of Wrist Pronation/Supination (degrees) [ Time Frame: During the intervention ]
  • Rapid Alternating Movements of Supination or Ankle plantar/dorsi-flexion (degrees) [ Time Frame: During the intervention ]
  • Peak power of local field potential oscillations (dB) [ Time Frame: During the intervention ]

Central Contacts and Locations

Central contacts

Madison Aasen, MS

612-505-8325aasen056@umn.edu

Sommer Amundsen-Huffmaster, PhD

612-301-1297slamunds@umn.edu

Locations

University of Minnesota, Movement Disorders Lab

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Madison Aasen, MS

612-505-8325aasen056@umn.edu

Principal Investigator:

Sommer Amundsen-Huffmaster, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • FOG
  • PD
  • Freezing of Gait
  • Parkinson disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-03-03.