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New treatment option for PTSD - Post Traumatic Stress Disorder
Official title Neuromodulation of the Hippocampus to Reduce Intrusive Re-Experiencing in PTSD: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06639061
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if non-invasive neurostimulation of memory-related brain areas works to treat intrusive memory symptoms in adults patients with posttraumatic stress disorder (PTSD). It will also learn about the effect of this neuromodulation procedure on reorganization of memory-related brain networks.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 65
You may be able to join if
- Aged of 20-65 years.
- Meet a diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale for DSM-5 - CAPS-5).
- CAPS-5 total score greater or equal to 33.
- Endorsement of intrusive symptoms (flashbacks, nightmares, or intrusive memories) with a frequency of at least 3 times a week.
- Meeting the accepted criteria for inclusion in an MRI examination.
You likely can't join if
- Meeting a diagnosis of Complex PTSD or personality disorder.
- 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 of the study protocol if the medication dosage is stable in the last...
- Exclusion rules in TMS research (see guidelines).
- Use of the following drugs: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir...
- Epilepsy or use of anti-epileptic drugs.
See the full eligibility criteria
- Aged of 20-65 years.
- Meet a diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale for DSM-5 - CAPS-5).
- CAPS-5 total score greater or equal to 33.
- Endorsement of intrusive symptoms (flashbacks, nightmares, or intrusive memories) with a frequency of at least 3 times a week.
- Meeting the accepted criteria for inclusion in an MRI examination.
- Meeting a diagnosis of Complex PTSD or personality disorder.
- 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 of the study protocol if the medication dosage is stable in the last three months and does not change during the study.
- Exclusion rules in TMS research (see guidelines).
- Use of the following drugs: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP...
- Epilepsy or use of anti-epileptic drugs.
- Traumatic head injuries or head surgery.
- Implanted metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker.
- Migraines
- Pregnant women
- Hearing problems
- Drinking alcohol 24 hours before the TMS session
- Repeated episodes of fainting with loss of consciousness and/or an event of fainting with loss of consciousness in the past year.
- The accepted exclusion criteria for an MRI examination
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.