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New treatment option for Parkinson Disease
Official title Neocortical Microarchitecture of Executive Function
ClinicalTrials.gov ID: NCT06778135
What this study is testing
- What it's testing
- This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85
You may be able to join if
- Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
- Aged 45-85
- Able to provide informed consent
- Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for...
- Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.
You likely can't join if
- Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
- Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
- Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
- Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.
- Evidence of a clinically significant abnormality on preoperative imaging.
See the full eligibility criteria
- Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
- Aged 45-85
- Able to provide informed consent
- Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease.
- Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.
- Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.
- Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.
- Able to tolerate 25 additional minutes of awake surgery.
- Able to participate and comply with tasks adequately, including instructions provided in English.
- Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
- Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
- Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
- Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.
- Evidence of a clinically significant abnormality on preoperative imaging.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.