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Characterization and modulation of traumatic memories in PTSD patients using TMS.
Study goals:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hippocampus Stimulation | Experimental |
| |
| Sham Stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv University | Tel Aviv | 69978 | Israel |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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