RecruitingPhase 2NCT06639061

Neuromodulation of the Hippocampus to Reduce Intrusive Re-Experiencing in PTSD: A Randomized Controlled Trial

Characterization and Modulation of Traumatic Memories in PTSD Patients Using Transcranial Magnetic Stimulation (TMS)

Sponsor

Tel Aviv University

Enrollment

60 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder Intrusive Memories of Traumatic Event(s)

Summary

The goal of this clinical trial is to learn if non-invasive neurostimulation of memory-related brain areas works to treat intrusive memory symptoms in adults patients with posttraumatic stress disorder (PTSD). It will also learn about the effect of this neuromodulation procedure on reorganization of memory-related brain networks. The main questions it aims to answer are: Does neuromodulation lower the number of times and the emotional severity participants intrusive memories? Does neuromodulation reduces the overall severity of PTSD? Researchers will compare neuromodulation targeting the hippocampus (a memory-related brain structure) to a control stimulation in an area not related to memory processes to see if hippocampus neuromodulation works to treat intrusive trauma memories and PTSD. Participants will: 1. Undergo magnetic resonance imaging (MRI) scans before and after neuromodulation to: a) determine a personalized neuromodulation target; and b) to measure changes in brain function from before to after treatment. 2. Receive hippocampus neuromodulation or a control neuromodulation once a week for 5 weeks. Keep a daily diary of their symptoms and the number of times they experience intrusive trauma memories.

Eligibility

Min Age: 20 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transcranial magnetic stimulation (TMS) — a non-invasive brain stimulation technique — targeted at the hippocampus (a memory-related brain region) can reduce flashbacks, nightmares, and intrusive memories in people with PTSD. **You may be eligible if...** - You are 20–65 years old with a confirmed PTSD diagnosis based on a structured clinical interview - Your PTSD is moderately severe or higher (CAPS-5 score ≥ 33) - You experience flashbacks, nightmares, or intrusive memories at least 3 times per week - You can safely undergo both MRI and TMS procedures **You may NOT be eligible if...** - You have complex PTSD, a personality disorder, psychosis, or bipolar disorder - You are on psychiatric medications that are not stable for at least 3 months - You have epilepsy or take anti-epileptic drugs - You have a history of serious head injury or have metal implants in your body - You are pregnant - You are taking certain drugs (e.g., cocaine, amphetamines, ketamine, alcohol within 24 hours of a session) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHippocampal stimulation using repetitive transcranial magnetic stimulation (rTMS)

We will use fMRI resting state data to personalize a TMS inhibitory stimulation to a cortical location that is the most strongly connected to a deeper left hippocampal target. 5 once a week sessions of rTMS will be delivered at 1-Hz stimulation frequency for 15 minutes following trauma memory reactivation.

DEVICESham stimulation using repetitive transcranial magnetic stimulation (rTMS)

We will use fMRI resting state data to personalize a TMS sham stimulation to a cortical location with near zero connectivity to a deeper left hippocampal target. 5 once a week sessions of rTMS will be delivered at 1-Hz stimulation frequency for 15 minutes following trauma memory reactivation.