Open-label, single-arm Phase I pilot (n=20) assessing a single 10 mg oral dose of psilocybin in adults with chronic pain who have implanted sensing-capable DBS devices; neural, sensory, and cognitive effects measured.
This open-label, single-arm pilot study investigates neural, sensory, and cognitive effects of a single 10 mg oral dose of psilocybin in participants with chronic pain who already have implanted sensing-capable deep brain stimulation devices.
Outcomes include multi-site neural recording from ambulatory DBS devices, quantitative sensory and cognitive testing, and self-reported pain; hypotheses are changes in functional connectivity, reductions in clinical and task-based pain, and improved cognition.
Single oral 10 mg psilocybin in patients with sensing-capable DBS devices.
Single medium oral dose (10 mg).