Post Traumatic Stress Disorder PTSD, Suicidal Ideation
Conditions
Keywords
Transcranial Magnetic Stimulation, Deep TMS, DTMS, PTSD, Suicidal Ideation, lPFC, Exposure, Treatment
Brief summary
The goal of this clinical trial is to evaluate whether deep transcranial magnetic stimulation (DTMS) using the H1-coil can safely and effectively reduce suicidal ideation in adults diagnosed with post-traumatic stress disorder (PTSD). The main questions it aims to answer are: (1) Does DTMS reduce suicidal ideation in adults with PTSD? (2) Does DTMS improve PTSD symptoms?. DTMS is administered together with a brief exposure procedure intended to activate trauma-related neural circuits before stimulation.
Detailed description
Post-traumatic stress disorder (PTSD) is characterized by intrusive re-experiencing, avoidance, emotional numbing, and hyperarousal symptoms, and is associated with substantial functional impairment and elevated risk for suicidal ideation. Pharmacologic and psychotherapeutic treatments, including selective serotonin reuptake inhibitors and trauma-focused therapies, can be effective but often result in incomplete response, high dropout rates, or difficulty tolerating trauma-focused interventions. These limitations highlight the need for additional therapeutic approaches for individuals who remain symptomatic. Deep Transcranial Magnetic Stimulation (DTMS) enables non-invasive modulation of neural circuits involved in fear extinction, emotional regulation, and suicidal ideation. The H1-coil is designed to stimulate deeper cortical regions than standard TMS coils, including areas within the lateral prefrontal cortex (LPFC) that are implicated in PTSD symptom expression and extinction learning. Prior feasibility studies have shown that high-frequency (HF) DTMS applied to the LPFC, particularly when combined with a brief trauma-related exposure, may reduce core PTSD symptoms and is well tolerated. This clinical trial evaluates whether HF DTMS using the H1-coil can reduce suicidal ideation in adults diagnosed with PTSD and active suicidal ideation. Each stimulation session is preceded by a brief script-driven exposure procedure designed to activate trauma-related neural circuits before DTMS. This exposure method has been shown to reliably elicit trauma-related responses and support extinction-based therapeutic mechanisms. The study is designed to assess whether DTMS targeting the prefrontal cortex, combined with controlled trauma-related exposure, can safely and effectively reduce suicidal ideation and PTSD symptoms in adults who remain symptomatic despite standard treatments.
Interventions
High-frequency Deep TMS delivered with the H1-coil. Each stimulation session is preceded by a brief script-driven exposure procedure intended to activate trauma-related neural circuits before stimulation
Sponsors
D.R. Rut Zaks OHAYON
Ben-Gurion University of the Negev
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
High-frequency Deep TMS using the H1-coil administered in a single-group, open-label design, with each session preceded by a brief script-driven exposure procedure.
Eligibility
Sex/Gender
ALL
Age
22 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Adults 22-68 years old * Male or female * Diagnosis of PTSD according to DSM-5 criteria * Active suicidal ideation at screening, confirmed by the Beck Scale for Suicide Ideation (SSI) * Able to provide informed consent * Stable psychiatric medication regimen for at least 4 weeks prior to enrollment (if applicable) * Able to comply with study procedures and attend scheduled sessions
Exclusion criteria
* Current psychotic disorder, bipolar disorder, or severe personality disorder * Substance use disorder within the past 3 months (excluding nicotine or caffeine) * Significant neurological disorder or history of seizures * Contraindications to TMS (e.g., metallic implants in the head, implanted medical devices, history of epilepsy) * Current use of medications that significantly lower seizure threshold * Pregnancy or breastfeeding * Acute medical illness or unstable medical condition * Cognitive impairment that would interfere with participation (based on MoCA) * Imminent risk requiring a higher level of care (e.g., hospitalization) * Prior non-response to adequate TMS treatment * Participation in another interventional study within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicidal Ideation Scale | Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months | Change in suicidal ideation severity, measured by the Beck Scale for Suicidal Ideation (SSI). The total score ranges from 0 to 38. Higher scores indicate greater severity of suicidal ideation (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity Scale | Screening, post-treatment (4 weeks), and follow-up at 1 and 2 months | Change in PTSD symptom severity measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The total symptom severity score ranges from 0 to 80 (20 symptoms, each rated 0-4). Higher scores indicate greater severity (worse outcome). |
| Self-Reported PTSD Symptoms Scale | Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months | Change in PTSD symptoms measured by the PTSD Checklist for DSM-5 (PCL-5). Total score ranges from 0 to 80 (20 items, each rated 0-4). Higher scores indicate greater severity (worse outcome). |
| Depressive Symptoms scale | Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months | Change in depressive symptoms measured by the Hamilton Depression Rating Scale (HDRS), 21-item version. Total score ranges from 0 to 52. Higher scores indicate greater severity of depression (worse outcome). |
| Cognitive safety | Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months | Change in cognitive performance measured by the Montreal Cognitive Assessment (MoCA). Total score ranges from 0 to 30. Higher scores indicate better cognitive performance (better outcome). A score of 26 or above is considered normal cognitive function. |
Countries
Israel
Contacts
CONTACTRut Zaks-Ohayon, PhD
CONTACTAbraham Zangen, Professor
PRINCIPAL_INVESTIGATORRut Zaks-Ohayon, PhD
Be'er Sheva Mental Health Center
STUDY_DIRECTORGai Geffen, PhD Candidate in Neuroscience
Ben-Gurion University of the Negev
STUDY_CHAIRAbraham Zangen, Professor
Ben-Gurion University of the Negev
Outcome results
None listed