Psilocybin With Intracranial Neural Sensing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psilocybin.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Psilocybin
10mg oral psilocybin
Primary outcome measures
- Changes in neural functional connectivity [Time frame: Drug administration to 90 days following]
Secondary outcome measures (1)
- Subjective changes in pain [Time frame: Drug administration to 90 days following]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06919640 · 23-39870 · 175145 · PR#202507H