Stress Disorders, Post-TraumaticNCT02853032

Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder

A study testing Active repetitive transcranial magnetic stimulation and robotic arm in people with Stress Disorders, Post-Traumatic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Active repetitive transcranial magnetic stimulation and robotic arm
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2017to 25 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female English-speaking active duty or recently retired veteran patients who have deployed post 9/11 receiving treatment at LRTC between the ages of 18-65 years;
Patients must have a diagnosis of PTSD confirmed by the Clinician-Administered PTSD Scale (CAPS-5) at screening,
Subjects must have a minimum PTSD Symptom Checklist (PCL-5) for DSM-V symptom severity rating of 25.

Who cannot join

Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder as documented in the medical record.
Substance use disorder during the 12 months prior to screening; except that Mild - Moderate, but not Severe, Alcohol Use Disorder (using DSM-5 criteria) will be allowed as determined by LRTC medical provider review.
Any history or signs of serious medical or neurological illness including seizure disorders. Except for seizures, a subject with a clinical abnormality may be included only if the study clinician considers the illness will not introduce additional risk and will not interfere with the study procedures. This will be determined during the screening phase via self-report and/or medical history review.
History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire.
Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their LRTC intake).
Any history or signs of metal objects deemed unsafe for MRI or that may adversely affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers, metal implants, etc.) in the body at the time of screening as indicated by self-report. MRI can have risks for persons with foreign bodies implanted in their body.

Trial locations and contacts

1 site in 1 country.

United States1 site

Laurel Ridge Treatment Center
San Antonio, Texas, 78259

Other trials in United States

About this study

Official title: Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder: a Double-Blind, Randomized Comparison to Sham Transcranial Magnetic Stimulation

Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the large variability in the magnitude of clinical outcomes reported is likely related to the current lack of knowledge of ideal side of stimulation (left vs right) and the limited precision in the targeting of brain circuits needed to obtain an optimal treatment response. In this protocol the investigators will: 1) generate individualized treatment plans based on an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based connectivity analysis to guide the delivery of adjunct, imaging-based \& robotically delivered rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program providing integrated evidence-based psychotherapy and pharmacological management (Treatment as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as other indicators of clinical change, to determine whether compared with TAU, addition of adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the potential correlation of connectivity changes with clinical outcomes.

Read the detailed description

The investigators propose a randomized, double-blind, sham-controlled, 20 consecutive day trial of adjunct rTMS to the right DLPFC for ADM with PTSD receiving TAU at Laurel Ridge Treatment Center (LRTC; San Antonio, TX). Methods: Consenting ADM receiving TAU for PTSD at LRTC will be randomized to receive 20 consecutive days of adjunct rTMS according to one of these two treatment arms: Arm 1 TAU plus rTMS to the right DLPFC and Arm 2 TAU plus sham rTMS. At UTHSCSA's Research Imaging Institute (RII), where all brain imaging will be conducted, rTMS treatment plans will be generated based on (pre-treatment) anatomical and functional magnetic resonance imaging (fMRI) to guide the optimal robotic positioning of the TMS coil to accurately target each subject's DLPFC. Initial diagnostic interview and weekly clinical follows ups will be conducted at the LRTC by research clinicians blinded to subjects' research group. A comparison of baseline brain connectivity measurements with subjects' neuroimaging follow ups conducted at treatment Week 3 will be conducted to identify network connectivity changes potentially associated to treatment response.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Active repetitive transcranial magnetic stimulation, robotic arm, Sham repetitive transcranial magnetic stimulation
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active repetitive transcranial magnetic stimulationDevice
Also called rTMS
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.
robotic armDevice
This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.
Sham repetitive transcranial magnetic stimulationDevice
Also called sham rTMS
The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.

Study groups in NCT02853032
Study group	Role	What they receive
Active rTMS to the right DLPFC	Active comparator	Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days. Receives: Device: Active repetitive transcranial magnetic stimulation; Device: robotic arm
Sham rTMS to the right DLPFC	Placebo comparator	Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, sham rTMS will be delivered at 20 Hz in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days. Receives: Device: robotic arm; Device: Sham repetitive transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)

Secondary outcomes (34)

Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
A clinically significant response is defined as at least a 50% decrease in the CAPS-5.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
A clinically significant response is defined as at least a 50% decrease in the CAPS-5.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
Remission is defined as a CAPS-5 score less than or equal to 29.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Measured: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
1. A traumatic event
2. At least one "Re-experiencing" symptom
3. At least one "Avoidance" symptom
4. At least two "Negative alterations in cognitions and mood" symptoms
5. At least two "Alterations in arousal and reactivity" symptoms
6. The trauma must last at least a month
7. The trauma must cause impairment
Remission is defined as a CAPS-5 score less than or equal to 29.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Functional Connectivity Changes (Measured by Resting-state Functional Magnetic Resonance Imaging) of the Targeted Brain Network(s) Following rTMS Treatment
Resting-state brain networks were identified using functional Magnetic Resonance Imaging. Any changes in the the targeted brain network (e.g. the sub-genual cingulate cortex) were reported using functional connectivity Z-scores. Functional connectivity Z-score indicates the number of standard deviations away from the baseline mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean, and lower connectivity, and positive numbers indicate values higher than the baseline mean, and higher connectivity
Measured: Baseline to three weeks (the conclusion of rTMS treatment)
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
This measure counts the number of participants with adverse events and serious adverse events.
Measured: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201725 Mar 2019

First posted2 Aug 2016 (estimated)
Study start5 Jul 2017
Primary completion25 Mar 2019
Study completion25 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, Post-TraumaticStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02853032
Sponsor's protocol ID: HSC20160191H
Status last verified: Oct 2020
First submitted: 25 Jul 2016
Last updated: 3 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to share individual participant data at this time.

Publications

Boggio PS, Rocha M, Oliveira MO, Fecteau S, Cohen RB, Campanha C, Ferreira-Santos E, Meleiro A, Corchs F, Zaghi S, Pascual-Leone A, Fregni F. Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. J Clin Psychiatry. 2010 Aug;71(8):992-9. doi: 10.4088/JCP.08m04638blu. Epub 2009 Dec 29.
PubMed 20051219
Fox PT, Salinas FS, Roache JD, Quinones M, Vaughan PW, Franklin C, Straud CL, Price L, Unzueta-Hernandez M, Woolsey MK, Chavez AM, Hoselton DA, Brundige AR, Litz BT, Young-McCaughan S, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Residential Therapy With Navigated Transcranial Magnetic Stimulation for Combat-Related PTSD: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e265110. doi: 10.1001/jamanetworkopen.2026.5110.
PubMed 41945348

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stress Disorders, Post-Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder: a Double-Blind, Randomized Comparison to Sham Transcranial Magnetic Stimulation
ClinicalTrials.gov ID: NCT02853032
Acronym / sponsor ID: HSC20160191H
Conditions: Stress Disorders, Post-Traumatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: Laurel Ridge Treatment Center, Consortium to Alleviate PTSD
Study start: 5 Jul 2017 (actual)
Primary completion: 25 Mar 2019 (actual)
Study completion: 25 Mar 2019 (actual)
First posted: 2 Aug 2016 (estimated)
Results: Posted 3 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active rTMS to the right DLPFC	Active comparator	Device: Active repetitive transcranial magnetic stimulation, Device: robotic armActive repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days.
Sham rTMS to the right DLPFC	Placebo comparator	Device: robotic arm, Device: Sham repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, sham rTMS will be delivered at 20 Hz in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female English-speaking active duty or recently retired veteran patients who have deployed post 9/11 receiving treatment at LRTC between the ages of 18-65 years;
Patients must have a diagnosis of PTSD confirmed by the Clinician-Administered PTSD Scale (CAPS-5) at screening,
Subjects must have a minimum PTSD Symptom Checklist (PCL-5) for DSM-V symptom severity rating of 25.

Key exclusion criteria (6 listed)

Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder as documented in the medical record.
Substance use disorder during the 12 months prior to screening; except that Mild - Moderate, but not Severe, Alcohol Use Disorder (using DSM-5 criteria) will be allowed as determined by LRTC medical provider review.
Any history or signs of serious medical or neurological illness including seizure disorders. Except for seizures, a subject with a clinical abnormality may be included only if the study clinician considers the illness will not introduce additional risk and will not interfere with the study procedures. This will be determined during the screening phase via self-report and/or medical history review.
History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire.
Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their LRTC intake).

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
Active repetitive transcranial magnetic stimulationAlso: rTMSThe MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.	Device	Active rTMS to the right DLPFC
robotic armThis robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.	Device	Active rTMS to the right DLPFC, Sham rTMS to the right DLPFC
Sham repetitive transcranial magnetic stimulationAlso: sham rTMSThe MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.	Device	Sham rTMS to the right DLPFC

Primary outcome

Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.

34 secondary outcomes

Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
Functional Connectivity Changes (Measured by Resting-state Functional Magnetic Resonance Imaging) of the Targeted Brain Network(s) Following rTMS Treatment
Time frame: Baseline to three weeks (the conclusion of rTMS treatment)
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active rTMS to Right DLPFC	60	51
Sham rTMS to the Right DLPFC	59	56

Primary outcome: Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)

Time frame: Baseline to three weeks (the conclusion of rTMS treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	Active rTMS to Right DLPFC n = 55	Sham rTMS to the Right DLPFC n = 58
baseline	59.82 (10.07)	60.45 (11.74)
3 weeks	33.29 (19.86)	39.14 (19.35)

Population analysed: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).

34 secondary outcomes are reported in the full results.

Adverse events

Time frame: Sixteen weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active rTMS to Right DLPFC	0 of 60 (0%)	36 of 60 (60%)	0 of 60
Sham rTMS to the Right DLPFC	0 of 59 (0%)	29 of 59 (49.2%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20051219Boggio PS, Rocha M, Oliveira MO, Fecteau S, Cohen RB, Campanha C, Ferreira-Santos E, Meleiro A, Corchs F, Zaghi S, Pascual-Leone A, Fregni F. Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. J Clin Psychiatry. 2010 Aug;71(8):992-9. doi: 10.4088/JCP.08m04638blu. Epub 2009 Dec 29.
Derived from this study: PubMed 41945348Fox PT, Salinas FS, Roache JD, Quinones M, Vaughan PW, Franklin C, Straud CL, Price L, Unzueta-Hernandez M, Woolsey MK, Chavez AM, Hoselton DA, Brundige AR, Litz BT, Young-McCaughan S, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Residential Therapy With Navigated Transcranial Magnetic Stimulation for Combat-Related PTSD: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e265110. doi: 10.1001/jamanetworkopen.2026.5110.
Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time.

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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. This study is not recruiting at the moment.

Felipe S Salinas, Ph.D. principal investigator

The University of Texas Health Science Center at San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Nov 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) (time frame: Baseline to three weeks (the conclusion of rTMS treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02853032, which also lists 2 linked publications.

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 3 Nov 2020.