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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how brain areas that control movement send messages in people with Parkinson’s disease. It is for adults ages 21–75 who are already planning deep brain stimulation (DBS) surgery at UMN. During surgery, the team will record brain signals using the DBS wire and a thin sensor strip placed through the same hole in the skull.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have idiopathic Parkinson’s disease, meaning its cause is unknown.
  • Have DBS surgery planned at UMN as part of your regular care.
  • Be 21–75 years old.

Who can't join

  • Have another major brain or nerve disorder that could affect the study results.
  • Have a history of dementia, which causes problems with memory and thinking.
  • Have problems or side effects after surgery that affect safety or the study results, such as muscle tightening caused by stimulation. These would prevent further study participation.
  • Are pregnant.
  • Have had radiation from research in the past year that, added to this study’s X-rays during surgery, would exceed a safe limit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MN