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

RecruitingPhase 2Ages 20 Years - 65 YearsAllTel Aviv University
NCT06639061 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 neuromodulat

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged of 20-65 years. * Meet a diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale for DSM-5 - CAPS-5). * CAPS-5 total score greater or equal to 33. * Endorsement of intrusive symptoms (flashbacks, nightmares, or intrusive memories) with a frequency of at least 3 times a week. * Meeting the accepted criteria for inclusion in an MRI examination. Exclusion Criteria: * Meeting a diagnosis of Complex PTSD or personality disorder. * Psychotic disorder, bipolar disorder, or a developmental neuropsychological disorder (autism, mental retardation). * Use of psychiatric medications (except for the medications listed in section 4.a of the study protocol if the medication dosage is stable in the last three months and does not change during the study. * Exclusion rules in TMS research (see guidelines). * Use of the following drugs: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma- hydroxybutyrate (GHB), alcohol, theophylline * Epilepsy or use of anti-epileptic drugs. * Traumatic head injuries or head surgery. * Implanted metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker. * Migraines * Pregnant women * Hearing problems * Drinking alcohol 24 hours before the TMS session * Repeated episodes of fainting with loss of consciousness and/or an event of fainting with loss of consciousness in the past year. * The accepted exclusion criteria for an MRI examination
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What it tests

  • Hippocampal stimulation using repetitive transcranial magnetic stimulation (rTMS)
  • Sham stimulation using repetitive transcranial magnetic stimulation (rTMS)
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Where

1 site
Tel Aviv University
Tel Aviv, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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