No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 75
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
25 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who are scheduled to have Deep Brain Stimulation surgery. Participants will have a small device placed in their brain to help understand how brain activity affects movement.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease.
I am aged between 21 and 75.
I am having DBS surgery at UMN as part of my routine care.
You may not be able to join if
I have another significant neurological disorder.
I have a history of dementia.
I have post-operative complications that affect my safety.
I am pregnant.
I had research radiation exposure in the last year that is unsafe.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 th…
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.
Trial Locations
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City
State
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Status
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
* P…
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
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