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Completed

NCT Number: NCT06372639

Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Characterization and modulation of traumatic memories in PTSD patients using TMS.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 69978, Israel

About this study

Study goals:

  • Characterization of the cortical brain regions that are suitable for effective modulation with TMS, which has the highest connectivity to the sub-cortical regions that are in the strongest connectivity with areas that directly contribute to the formation and preservation of intrusive traumatic memories.
  • Examine the modulation of those cortical brain regions with TMS, while deliberately re-activating an intrusive traumatic memory, on the clinical symptoms of PTSD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 20-65 of both sexes, who meet the diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale - CAPS-5). The clinical interview will be performed by clinical psychologists.
  • CAPS-5 (Clinician-Administered PTSD Scale) score higher than 33.
  • Subjects who experience intrusive symptoms (flashbacks, nightmares, or intrusive memories) at least 4 times a week.
  • Only subjects with a level of Hebrew that allows a full understanding of the consent form to participate in the experiment will be included in the experiment.
  • In addition, the accepted criteria for inclusion for an MRI examination for medical purposes will be applied, according to the established procedures at the MRI Institute at the Sourasky Tel Aviv Medical Center and at the Imaging Center at Tel Aviv University.

Exclusion criteria

  • Subjects who meet the diagnosis of Complex PTSD or personality disorder.
  • Subjects who suffer or have suffered in the past from a 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) will not be an expense criterion if the medication dosage is stable in the last three months and does not change during the study.

In addition, exclusion criteria 4-13 will apply according to the exclusion rules in TMS laboratories in England and the USA:

  • Use of the following drugs:

a. The list of drugs that constitute a criterion for exclusion in the study: imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma- hydroxybutyrate (GHB), alcohol, theophylline

  • Subjects suffering from epilepsy or taking anti-epileptic drugs.
  • Victims with traumatic head injuries or who have undergone head surgery.
  • Having a metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker in their body.
  • Subjects suffering from migraines
  • Pregnant women
  • Subjects with hearing problems
  • Subjects who use drugs
  • Subjects who drank alcohol 24 hours before the experiment
  • Subjects who have previously experienced repeated episodes of fainting with loss of consciousness and/or an event of fainting with loss of consciousness in the past year. (reaction and vegalit)
  • In addition, the accepted exclusion criteria for an MRI examination for medical purposes will apply, according to the established procedures at the MRI Institute at the Sourasky Tel Aviv Medical Center and at the Imaging Center at Tel Aviv University.

Treatment and study plan

Trans-Cranial Magnetic Stimulation

Device

Brain stimulation by the TMS device will be given after a deliberate memory re-activation, using repetitive pulses at 1Hz frequency for 15 minutes, the target area will be determined based on an fMRI scan in the resting state of the subject.

Primary outcomes

  1. CAPS-5 score

    Time frame: Baseline, second measure after up to 12 weeks and last measure after up to 24 weeks.

    The CAPS-5 is a 30-item structured interview that can be used to make current (past month or week) diagnosis of PTSD & make lifetime diagnosis of PTSD.

  2. Neurological measures of functional connectivity

    Time frame: Baseline, after up to 12 weeks

    Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups over time.

  3. Intrusive memories

    Time frame: Daily for up to 12 weeks

    The amount, frequency and emotional effect of intrusive traumatic memories, measured by a daily self-report of the subject.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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