- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853032
Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78259
- Laurel Ridge Treatment Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active rTMS to the right DLPFC
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.
|
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.
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.
Other Names:
|
PLACEBO_COMPARATOR: Sham rTMS to the right DLPFC
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.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to three weeks (the conclusion of rTMS treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
A clinically significant response is defined as at least a 50% decrease in the CAPS-5. |
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
A clinically significant response is defined as at least a 50% decrease in the CAPS-5. |
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
Remission is defined as a CAPS-5 score less than or equal to 29. |
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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:
Remission is defined as a CAPS-5 score less than or equal to 29. |
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)
|
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.
|
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)
|
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.
|
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)
|
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
|
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)
|
This measure counts the number of participants with adverse events and serious adverse events.
|
Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20160191H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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