NCT06639061 Neuromodulation of the Hippocampus to Reduce Intrusive Re-Experiencing in PTSD: A Randomized Controlled Trial
| NCT ID | NCT06639061 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tel Aviv University |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-11-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Yair Bar-Haim, PhD
PRINCIPAL INVESTIGATOR
Tel Aviv University
Frequently Asked Questions
Who can join the NCT06639061 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06639061 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06639061 currently recruiting?
Yes, NCT06639061 is actively recruiting participants. Contact the research team at yair1@tauex.tau.ac.il for enrollment information.
Where is the NCT06639061 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT06639061 clinical trial?
NCT06639061 is sponsored by Tel Aviv University. The principal investigator is Yair Bar-Haim, PhD at Tel Aviv University. The trial plans to enroll 60 participants.
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