RECRUITING

Neocortical Microarchitecture of Executive Function

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Conditions

Parkinson Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Quick Facts

Study Start:2025-07-25
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06778135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
  2. 2. Aged 45-85
  3. 3. Able to provide informed consent
  4. 4. Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease.
  5. 5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.
  6. 6. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.
  7. 7. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.
  8. 8. Able to tolerate 25 additional minutes of awake surgery.
  9. 9. Able to participate and comply with tasks adequately, including instructions provided in English.
  1. 1. Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
  2. 2. Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
  3. 3. Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
  4. 4. Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.
  5. 5. Evidence of a clinically significant abnormality on preoperative imaging.

Contacts and Locations

Study Contact

Pamela David Gerecht, PhD
CONTACT
303-724-4134
pamela.davidgerecht@cuanschutz.edu

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-07-25
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease