Percept recordings of brain activity during freezing of gait in Parkinson's disease

Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease

This research will use the Medtronic Percept DBS device to test whether brain electrical patterns differ during walking, movement transitions, and freezing in people with Parkinson's disease who do and do not experience freezing of gait.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT06848205 on ClinicalTrials.gov

What this trial studies

This protocol uses the Medtronic Percept™ deep brain stimulation system to record local field potentials (LFPs) in people with Parkinson's disease with and without freezing of gait. Three experiments compare LFPs during gait initiation with and without external cues, during a FOG provocation course comparing successful transitions versus freezing episodes, and during rapid alternating wrist/foot movements. Participants are tested off Parkinson's medications and with DBS turned off, and may volunteer for one or more experiments performed at the University of Minnesota Movement Disorders Lab. The aim is to identify oscillatory biomarkers tied to freezing and cueing that could inform future targeted therapies or device programming.

Who should consider this trial

Good fit: Adults aged 21–75 with idiopathic Parkinson's disease who have an implanted Medtronic Percept neurostimulator, can walk independently for at least 50 meters, and are at least three months post‑activation of their device are ideal candidates.

Not a fit: People without a Percept implant, those with other neurodegenerative disorders (e.g., dementia with Lewy bodies, MSA, Alzheimer's), or those unable to ambulate independently are not likely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the work could identify brain-signal markers that help guide cueing strategies or adaptive DBS to reduce freezing episodes.

How similar studies have performed: Recording LFPs with implanted DBS devices has identified biomarkers for Parkinsonian tremor and bradykinesia, but using Percept recordings specifically to characterize freezing of gait and cueing responses is relatively novel and still exploratory.

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.

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota, Movement Disorders Lab — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Madison Aasen, MS

Conditions Freezing of Gait; Parkinson Disease; FOG; PD; Parkinson disease