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

Launched by TEL AVIV UNIVERSITY · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with Post-Traumatic Stress Disorder (PTSD) who experience intrusive memories, such as flashbacks or nightmares. The researchers want to find out if a non-invasive technique called neuromodulation, which targets a specific area of the brain related to memory (the hippocampus), can help reduce the number and emotional intensity of these intrusive memories. Participants will receive this treatment once a week for five weeks, and they will also keep a daily diary to track their symptoms. The study includes brain scans before and after treatment to see how this approach affects brain function and memory.

To join the trial, participants should be between 20 to 65 years old and have a diagnosis of PTSD based on a specific assessment. They need to experience intrusive memories at least three times a week. However, certain conditions, like complex PTSD, severe mental health disorders, or recent substance use, may exclude individuals from participating. This trial is currently recruiting, and it offers a potential new way to help those struggling with the effects of trauma.

Gender

ALL

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