Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920 | Recruiting

• 1 other identifier: NEURO-2016-24971
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation

  The pallidothalamic pathway is what connects the two locations of the brain from which we are recording (GPi and motor cortex). We will also see how the two sets of stimulation made a difference in measurements of bradykinesia (slowness of movement): how long it took for the participant to get ready to move, how fast they started moving, and how long it took them to touch the startpad.

  post-surgery (1 day)

• The relationship (slope) between the measures of bradykinesia and total pathway activation

  will be estimated via a linear mixed-effects (LME) model that considers multiple subjects and multiple observations within subject

  post-surgery (1 day)

Study Arms (1)

Study group

EXPERIMENTAL

Parkinson's patients with DBS surgery planned as part of routine clinical care

Other: DBS stimulation

Interventions

DBS stimulation OTHER

* Standard of care DBS surgery * stimulation through the DBS lead during their DBS lead surgery, the study team will use 2 sets of stimulation settings on each participant: 1. Stimulation through the DBS contact whose electrical activity is the MOST similar to the area of the brain that controls movement 2. Stimulation through the DBS contact whose electrical activity is the LEAST similar to the area of the brain that controls movement

Study group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD
• DBS surgery at UMN is planned as part of routine clinical care
• Aged 21-75

You may not qualify if:

• Other significant neurological disorder, which may confound neurophysiological changes associated with Parkinson's disease
• History of dementia
• Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
• Pregnant women
• Known research radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Joshua E Aman

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Brown, RN

CONTACT

(612) 301-2140; ksbrown@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)