Psilocybin With Intracranial Neural Sensing
NCT06919640 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-06-06
Summary
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.
Conditions
Interventions
- DRUG
-
10mg oral psilocybin
Sponsors & Collaborators
-
Joshua Woolley, MD, PhD
lead OTHER
Principal Investigators
-
Joshua Woolley, MD/PhD · University of California, San Francisco
-
Prasad Shirvalkar, MD/PhD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2028-04-30
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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