Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Device: Trans-Cranial Magnetic Stimulation

• Registration Number: NCT06372639
• Lead Sponsor: Tel Aviv University

Brief Summary

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

Detailed Description

Study goals:

1. 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.

2. 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.

Study Timeline

• Study Start: 2022-02-23
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Status Verified: 2024-10
• Primary Completion: 2024-10-24
• Study Completion: 2024-10-24
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 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.
2. CAPS-5 (Clinician-Administered PTSD Scale) score higher than 33.
3. Subjects who experience intrusive symptoms (flashbacks, nightmares, or intrusive memories) at least 4 times a week.
4. 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.
5. 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.

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Exclusion Criteria

1. Subjects who meet the diagnosis of Complex PTSD or personality disorder.

2. Subjects who suffer or have suffered in the past from a psychotic disorder, bipolar disorder, or a developmental neuropsychological disorder (autism, mental retardation).

3. 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:

4. 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

5. Subjects suffering from epilepsy or taking anti-epileptic drugs.

6. Victims with traumatic head injuries or who have undergone head surgery.

7. Having a metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker in their body.

8. Subjects suffering from migraines

9. Pregnant women

10. Subjects with hearing problems

11. Subjects who use drugs

12. Subjects who drank alcohol 24 hours before the experiment

13. 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)

14. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Trans-Cranial Magnetic Stimulation	-
Hippocampus Stimulation	Trans-Cranial Magnetic Stimulation	-

Primary Outcome Measures

Name	Time	Method
CAPS-5 score	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.
Intrusive memories	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.
Neurological measures of functional connectivity	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.

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel