Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06692920

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

DBS stimulation

Study Details

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

Study ID

NCT06692920

Start date

Dec 1, 2024

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Study group

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

Interventions

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

Primary outcome measure

  • amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation [ Time Frame: post-surgery (1 day) ]
  • The relationship (slope) between the measures of bradykinesia and total pathway activation [ Time Frame: post-surgery (1 day) ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

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 2026-03-16.