Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Post Traumatic Stress Disorder Clinical Trial

Official title:

Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372639
• Other study ID #: TAU-PTSD-TMS
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: November 24, 2024

Study information

• Verified date: April 2024
• Source: Tel Aviv University
• Contact: Yair Bar-Haim, PhD
• Phone: +97236405465
• Email: yair1[@]post.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 24, 2024
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Trans-Cranial Magnetic Stimulation
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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS-5 score	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.	Baseline, second measure after up to 12 weeks and last measure after up to 24 weeks.
Primary	Neurological measures of functional connectivity	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.	Baseline, after up to 12 weeks
Primary	Intrusive memories	The amount, frequency and emotional effect of intrusive traumatic memories, measured by a daily self-report of the subject.	Daily for up to 12 weeks