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
45 – 85
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
15 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who need deep brain stimulation surgery. Participants will have a small probe inserted into their brain while they are awake, and this will help doctors learn more about brain function.
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 between 45 and 85 years old
I can provide informed consent
I have mild impairments in executive function
I am medically fit for deep brain stimulation surgery
The surgical plan will allow access to my dorsal lateral prefrontal cortex
I can tolerate awake surgery
I can follow instructions in English
You may not be able to join if
I have moderate or severe cognitive impairment
I cannot handle awake surgery
I cannot safely access the dorsal lateral prefrontal cortex
I have moderate or severe deficits in executive function
I have a significant abnormality on preoperative imaging
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.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
2. Aged 45-85
3. Able to provide informed consent
4. Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, wi…
Inclusion Criteria:
1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
2. Aged 45-85
3. Able to provide informed consent
4. Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease.
5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.
6. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.
7. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.
8. Able to tolerate 25 additional minutes of awake surgery.
9. Able to participate and comply with tasks adequately, including instructions provided in English.
Exclusion Criteria:
1. Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
2. Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
3. Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
4. Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.
5. Evidence of a clinically significant abnormality on preoperative imaging.
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