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

March 13, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to understand the relationship between network brain activity and motor signs of Parkinson's disease, and to determine if brain activity can predict optimal locations or network pathways for stimulation. During deep brain stimulation lead placement surgery, research participants will have an FDA approved ECoG strip placed through the DBS lead burr hole over the primary motor cortex. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously while the participant performs a reach-to-target motor task, to understand how different brain regions communicate and are associated with motor signs of Parkinson's disease. The study team will look for specific brain activity biomarkers hypothesized to be associated with Parkinson's disease and will then direct stimulation through the DBS lead toward regions showing those biomarkers and compare to stimulation directed to areas not showing the specified biomarkers. Neural pathways being activated by stimulation and behavioral measures of the reach task will be compared between the two stimulation conditions.

Intervention:

  1. Stimulation through the DBS lead contact showing the most coherence with brain activity in the motor cortex
  2. Stimulation through the DBS lead contact showing the least coherence with brain activity in the motor cortex

During the mapping session patients will either be asked to perform motor tasks such as finger-tapping, pronating/supinating the wrist, manipulating a joystick, or pointing to targets on a touch-sensitive, LCD positioned in front of them. Patients may also be asked to perform cognitive tasks such as maintaining items in working memory or deciding between potentially rewarding stimuli with either a joystick or a finger response pad.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kelly Brown, RN
  • Phone Number: (612) 301-2140
  • Email: ksbrown@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Parkinson's patients with DBS surgery planned as part of routine clinical care
Other: DBS stimulation
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation
Time Frame: post-surgery (1 day)
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
Time Frame: post-surgery (1 day)
will be estimated via a linear mixed-effects (LME) model that considers multiple subjects and multiple observations within subject
post-surgery (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Joshua E Aman, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEURO-2016-24971

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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