Psilocybin With Intracranial Neural Sensing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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10mg oral psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

10mg oral psilocybin

Interventions

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Psilocybin

10mg oral psilocybin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No