Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Temporary implatation of large-scale intracranial electrode. for Parkinson Disease

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 registry: https://clinicaltrials.gov/study/NCT06778135 · University of Colorado, Denver · enrollment listed as 15

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Temporary implatation of large-scale intracranial electrode., or brain electrode. The registry lists allocation as na. This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain.

They plan to enroll about 15 people at Aurora. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology

Interventions: Temporary implatation of large-scale intracranial electrode., brain electrode

Primary outcome (registry wording): Measure the neural population representations of task parameters along, and within, the cortical layers.

Who it is for (from inclusion criteria)

  • Ages 45 Years to 85 Years
  • Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
  • 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

Public study contact (from the registry)

Pamela David Gerecht, PhD

303-724-4134

pamela.davidgerecht@cuanschutz.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.

NCT01581580 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)

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NCT04375280 · Official ClinicalTrials.gov record · University Hospital, Clermont-Ferrand

FAQ about this NCT record

Is NCT06778135 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06778135?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06778135?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary