Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

NCT ID: NCT06372639

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2024-10-24

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Hippocampus Stimulation

Group Type: EXPERIMENTAL

Trans-Cranial Magnetic Stimulation

Intervention Type: 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.

Sham Stimulation

Group Type: SHAM_COMPARATOR

Trans-Cranial Magnetic Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Yair Bar-Haim

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel Aviv University

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

TAU-PTSD-TMS

Identifier Type: -

Identifier Source: org_study_id