Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Sponsor
University of New Mexico
Study ID
NCT07745569
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    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.
  • Psilocybin (drug) — 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.
  • Neurofeedback — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Arm 1: Neurofeedback
    You will undergo 2 sessions of neurofeedback treatment, with an interval of 1-2 weeks between sessions up to a month maximum. Neurofeedback training and treatment in this study is performed inside an MRI scanner while wearing a cap to measure brain waves (EEG). You will be lying comfortably inside an MRI machine for 1 hour while your brain activity is being scanned. You will see a screen with a thermometer-style red bar, which will represent activity of a specific region of your brain (the amygdala), involved in emotion experience in the active condition. For those assigned to the sham condition, the red bar will not represent brain activity and will move randomly. By controlling the height of the red bar in real time, you will be able to try to regulate activity of that brain region. By controlling the neurofeedback signal, you may learn to enhance your brain activity associated with happy future thoughts.
  • Active Comparator: Arm 2: TMS
    The day before you begin the rTMS treatments, you will be asked to come in for a short visit to determine the level of stimulation that is right for you. You will then receive up to 100 rTMS treatments, given five days a week for 10 days. For the first 50 treatments, you will receive real stimulation to the left side of your brain. After 50 treatments to the left side, depending on how it affects you, you may qualify to receive 50 more treatments to the right side of your brain. You might feel a slight twitch in your hand. A camera will track your head movements during the procedure. Most people experience tapping or twitching on their scalp during rTMS. The stimulation will last 10 minutes, followed by 30 minutes of rest before another session.
  • Active Comparator: Arm 3: Psilocybin
    You may receive 2 psilocybin assisted therapy treatments, given once a week, for 2 weeks. Preparation Sessions: Before the first psilocybin session, you will meet with the study therapist and physician for 1-2 preparation meetings, to answer questions and make sure you understand the sequence of events during the intervention. Psilocybin Session: You will lie on a comfortable couch, receive the medication and be guided through the psychedelic experience with the two trained study staff, while being medically monitored, for approximately 8 hours. If needed, you may receive medications to treat side effects like high blood pressure, or anxiety. You will need to have a trusted person to take you home and stay with you for the night after each psilocybin session. Integration Session: The next day after each psilocybin session, you will meet with the therapist again and talk about your experience. Depending on what you experienced in the first week, the dose may be increased.

Primary Outcome Measure

Neurofeedback [ Time Frame: From enrollment through post-treatment visit about 6-8 weeks. ]

Central Contacts

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