Psilocybin With Intracranial Neural Sensing

This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, quantitative sensory and cognitive testing, and self-reports of pain. We hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.

Inclusion criteria

• Currently implanted chronic brain sensing device (such as RC+S or Percept)
• Not currently enrolled in another trial
• Ability to speak and read English
• Able to attend all in-person and virtual visits
• No changes in medication or major surgical procedures anticipated for the trial
• Able to identify someone to accompany from the research unit at the end of drug administration day or agreement to have a study team member accompany them from the research unit

Exclusion criteria

• A health condition that makes this study unsafe or unfeasible, determined by study physicians
• Use of medication, vitamins, or supplements and unwilling or unable to discontinue medications that have problematic interactions with psilocybin
• Adulthood epilepsy or other seizure disorder
• Require supplemental oxygen
• Medical finding or diagnosis that would make participation in this trial unsafe