Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Summary

PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.

Conditions

• PTSD
• PTSD - Post Traumatic Stress Disorder
• Major Depression
• Suicidality

Interventions

DEVICE

Transcranial Magnetic Stimulation

This intervention will deliver open-label aiTBS, an efficient FDA-cleared form of rTMS for major depressive disorder to patients with intermediate/high risk (i.e., significant depression and anxiety; chronic suicidal ideation). The study team will conduct modeling of the electric field intensity and distribution for each participant, and provide proof of concept for an electric-field informed dosing strategy that engages brain networks.

DRUG

Psilocybin (drug)

In this intervention, open-label flexible-dosing of psilocybin assisted therapy in intermediate and high-risk patients will be delivered to reduce suicidal ideation and identify mediators of response. The study team will deliver two separate psilocybin sessions accompanied by preparation and integration therapy. Factors such as dose, depression severity, serotonergic use, and depth of mystical experiences will be correlated with suicidality reduction.

BEHAVIORAL

Neurofeedback

This intervention will deliver active or sham real-time fMRI neurofeedback occurring across two visits to a low-to-intermediate risk population, i.e., low-to-severe levels of depression or anxiety/PTSD identified by clinical scales, with suicidal ideation present but no intent or plan.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• The Mind Research Network

  collaborator OTHER

• University of New Mexico

  lead OTHER

Principal Investigators

• Davin Quinn, MD · University of New Mexico

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

2026-08-31

Primary Completion

2030-06-30

Completion

2030-06-30

FDA Drug

Yes

FDA Device

Yes