Post Traumatic Stress Disorder PTSDDTMS-PTSD-SINCT07880340
Deep TMS for PTSD With Suicidal Ideation
A study testing Deep Transcranial Magnetic Stimulation (DTMS) in people with Post Traumatic Stress Disorder PTSD and Suicidal Ideation, run by D.R. Rut Zaks OHAYON at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD, Suicidal Ideation
- What is being tested?
- Deep Transcranial Magnetic Stimulation (DTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Be'er Sheva Mental Health Center
Beersheba
Rut Zaks-Ohayon, PhD, 052-5524883, rut.zaks@pbsh.health.gov.il
Gai Geffen, PhD candidate in Neuroscience, 0528895035, dTMS.ptsd@gmail.com
About this study
Official title: A Prospective Study to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation (DTMS) for the Treatment of PTSD-Associated Suicidal Ideation (PTSD-SI)
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.
Read the 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.
- Being tested
- Deep Transcranial Magnetic Stimulation (DTMS)
- Keywords
- Transcranial Magnetic Stimulation, Deep TMS, DTMS, PTSD, Suicidal Ideation, lPFC, Exposure, Treatment
- Medical subject headings
- Combat Disorders, Suicidal Ideation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Transcranial Magnetic Stimulation (DTMS)Device
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
| Study group | Role | What they receive |
|---|---|---|
| DTMS with Exposure | Experimental | High-frequency Deep TMS using the H1-coil, with each session preceded by a brief script-driven exposure procedure. Receives: Device: Deep Transcranial Magnetic Stimulation (DTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D.R. Rut Zaks OHAYON
- Sponsor type
- Other government
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor-investigator, D.R. Rut Zaks OHAYON, Beersheva Mental Health Center
- Investigators
- Rut Zaks-Ohayon, PhD, Principal investigator, Be'er Sheva Mental Health CenterGai Geffen, PhD Candidate in Neuroscience, Study director, Ben-Gurion University of the NegevAbraham Zangen, Professor, Study chair, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880340
- Sponsor's protocol ID
- MHC-0012-24
- Other IDs
- MOH_2026-07-14_016934
- Acronym
- DTMS-PTSD-SI
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation (DTMS) for the Treatment of PTSD-Associated Suicidal Ideation (PTSD-SI)
- ClinicalTrials.gov ID
- NCT07880340
- Acronym / sponsor ID
- DTMS-PTSD-SI / MHC-0012-24
- Keywords
- Transcranial Magnetic Stimulation, Deep TMS, DTMS, PTSD, Suicidal Ideation, lPFC, Exposure, Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- D.R. Rut Zaks OHAYONOther government
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| DTMS with Exposure | Experimental | Device: Deep Transcranial Magnetic Stimulation (DTMS)High-frequency Deep TMS using the H1-coil, with each session preceded by a brief script-driven exposure procedure. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | DTMS with Exposure |
Primary outcome
Change in Suicidal Ideation Scale
Time frame: 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).
4 secondary outcomes
PTSD Symptom Severity Scale
Time frame: Screening, post-treatment (4 weeks), and follow-up at 1 and 2 months
Self-Reported PTSD Symptoms Scale
Time frame: Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Depressive Symptoms scale
Time frame: Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Cognitive safety
Time frame: Screening, post-treatment (4 weeks), and follow-up visits at 1 and 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rut Zaks-Ohayon, PhD principal investigator
Be'er Sheva Mental Health Center
Gai Geffen, PhD Candidate in Neuroscience study director
Ben-Gurion University of the Negev
Abraham Zangen, Professor study chair
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Transcranial Magnetic Stimulation (DTMS) in people with Post Traumatic Stress Disorder PTSD and Suicidal Ideation, run by D.R. Rut Zaks OHAYON at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rut Zaks-Ohayon, PhD (052-5524883, rut.zaks@pbsh.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation Scale (time frame: Screening, baseline, 2-week visits, post-treatment (4 weeks), and follow-up visits at 1 and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.