Actively Recruiting

Phase 2
Age: 20Years - 65Years
All Genders
NCT06639061

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

Led by Tel Aviv University · Updated on 2024-11-01

60

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 20 to 65 years
  • Diagnosed with PTSD according to DSM-5 using Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  • CAPS-5 total score of 33 or higher
  • Experience intrusive symptoms (flashbacks, nightmares, or intrusive memories) at least 3 times a week
  • Eligible for MRI examination
Not Eligible

You will not qualify if you...

  • Diagnosis of Complex PTSD or personality disorder
  • Psychotic disorder, bipolar disorder, or developmental neuropsychological disorder (autism, mental retardation)
  • Use of psychiatric medications except stable doses of allowed medications for at least three months
  • Use of certain drugs including imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, MDMA, phencyclidine, ketamine, GHB, alcohol, theophylline
  • Epilepsy or use of anti-epileptic drugs
  • History of traumatic head injuries or head surgery
  • Implanted metallic body devices, electrodes, or pacemaker (except approved fillings, amalgam, or orthodontic fixations)
  • Migraines
  • Pregnant women
  • Hearing problems
  • Drinking alcohol within 24 hours before TMS session
  • Repeated fainting with loss of consciousness or fainting within the past year
  • Any criteria that exclude from MRI examination
  • Exclusion criteria from TMS research guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tel Aviv University

Tel Aviv, Israel

Actively Recruiting

Loading map...

Research Team

Y

Yair Bar-Haim, PhD

CONTACT

N

Nitzan Censor, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here