An interventional study of Deep Transcranial Magnetic Stimulation (DTMS) in Post Traumatic Stress Disorder PTSD and Suicidal Ideation, sponsored by D.R. Rut Zaks OHAYON. Not yet recruiting at 1 site in Israel. Open to participants aged 22 Years to 68 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by D.R. Rut Zaks OHAYON · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Combat Disorders; 71 are open to participants now.
This study's planned enrollment of 72 is close to the median of 72 across 119 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →This is the only study on the registry with D.R. Rut Zaks OHAYON as lead sponsor.
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Exclusion Criteria:
High-frequency Deep TMS using the H1-coil, with each session preceded by a brief script-driven exposure procedure.
Device: Deep Transcranial Magnetic Stimulation (DTMS)
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
Change in Suicidal Ideation Scale
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).
Time frame: Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
PTSD Symptom Severity Scale
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).
Time frame: Screening, post-treatment (4 weeks), and follow-up at 1 and 2 months
Self-Reported PTSD Symptoms Scale
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).
Time frame: Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Depressive Symptoms scale
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).
Time frame: Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Cognitive safety
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.
Time frame: Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Neurophysiological Measure 1: Resting-state QEEG
Change in resting-state quantitative EEG (QEEG), measured as the Z-score of band power in the theta band (4-8 Hz) at frontal sites. Z-scores are computed against a normative database; units are standard deviations (Z-scores).
Time frame: Baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 month
Neurophysiological Measure 2: TMS-evoked potentials (TEP)
Change in the amplitude (microvolts; µV) of the TMS-evoked potential (TEP) components (P30, N45, P60, N100) at the stimulation site, recorded by EEG in response to single TMS pulses (TEP assessments) before the TMS treatment.
Time frame: Baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 month
Neurophysiological Measure 3: repeated TMS evoked potential
Change in spectral power of the repetitive TMS-evoked potential (rTEP) at the stimulation site, recorded by EEG during high-frequency stimulation trains (the treatment itself). EEG data will be transformed to the frequency domain, and power will be computed in predefined frequency bands (theta, alpha, beta, low gamma). Units of measure: dB / percent change from baseline.
Time frame: Baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 month
Plan to share: No — Individual participant data will not be shared
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2029, 28 months later.
Of 57 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 28 months is above that.
Counting every sponsor, half of 63 studies reached it within 23 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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