Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies (NCT07745569) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
150 participantsStarted 2026-08-31
Plain-language 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.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18-69 years old
. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.
. Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional.
. Must be under the care of a medical provider (ex: primary care, therapist, psychiatrist, psychiatric nurse practitioner) for mental health treatment who can provide contact information and written confirmation that they will be willing and able to care for participant during their entire involvement in the study.
Exclusion criteria
. A prior history of other central nervous system disease or any history of seizures;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still in Phase 2 and hasn't started recruiting yet — given that, how much is currently known about the safety of combining electromagnetic and psychedelic therapies for PTSD and major depression, and would waiting for more data be worth considering?
2Since suicidality is listed as one of the conditions being studied, how would my safety be monitored throughout the trial, and what happens if my symptoms worsen while I'm participating?
3The trial is measuring neurofeedback as a primary outcome — can you help me understand what that means in practice, and what the sessions might actually involve week to week if I were to enroll?
4Since the trial isn't recruiting yet, are there currently available standard treatments for PTSD or major depression that I should try first while this study is still in the planning phase?
5Given that this involves psychedelic therapies, are there any health conditions, medications I'm already taking, or personal history factors that would make this kind of trial potentially riskier for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurofeedback
Timeframe: From enrollment through post-treatment visit about 6-8 weeks.
. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);
. history of current or recent (within one year) substance/alcohol use disorder, with the exception of tobacco use disorder;
. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study;
. presence of any implanted metal or electrical device (e.g. pacemaker);
. recent medical hospitalization (within three weeks);
. any condition that would prevent the participant from completing the protocol, such as significant agitation;
. appointment of a legal representative or treatment guardian;