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Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

NCT07484906 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-03-20

No results posted yet for this study

Summary

PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy.

Conditions

Interventions

BEHAVIORAL

fMRI Neurofeedback

Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI.

DEVICE

Accelerated theta burst stimulation

Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex.

DRUG

Psilocybin assisted therapy

Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions.

Sponsors & Collaborators

  • The Mind Research Network

    collaborator OTHER

  • Georgia State University

    collaborator OTHER

  • New Mexico VA Healthcare System

    collaborator FED

  • Washington University School of Medicine

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484906 on ClinicalTrials.gov