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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06692920
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

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 Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Study group
    Parkinson's patients with DBS surgery planned as part of routine clinical care

Primary Outcome Measure

amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation [ Time Frame: post-surgery (1 day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Niecy Beltz
[email protected]
612-626-5711

Find similar trials in Minneapolis, MN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Minnesota· Minneapolis, MN

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