Psilocybin With Intracranial Neural Sensing

Phase 1

Not yet recruiting

• Conditions: Chronic Pain
• Interventions: Drug: Psilocybin

• Registration Number: NCT06919640
• Lead Sponsor: Joshua Woolley, MD, PhD

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-05-01
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10mg oral psilocybin	Psilocybin	-

Primary Outcome Measures

Name	Time	Method
Changes in neural functional connectivity	Drug administration to 90 days following	Measured by high-gamma coherence, cross-correlations, and Granger Causality

Secondary Outcome Measures

Name	Time	Method
Subjective changes in pain	Drug administration to 90 days following	Measured by subjective pain scales

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States