Clinical Trial

Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Study acronym: PRE-EMPT
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07745569
Lead Sponsor University of New Mexico
Collaborators: United States Department of Defense, The Mind Research Network
Conditions PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression, Suicidality
Enrollment 150 participants
Start Date 2026-08-31
Primary Completion 2030-06-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-04