Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ketamine, Stellate Ganglion Blocks and Combination Treatment to Sham Therapies for Traumatic Brain Injury-Associated Headaches and Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios.

Primary Objectives:

1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache;
2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD;
3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD;
4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance;
5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.

Secondary Objectives:

1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site).
2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder; Posttraumatic Headache
• Intervention / Treatment: Procedure: Group A active comparator; Drug: Group B active comparator; Combination product: Group C Experimental; Other: Group D Placebo Comparator

Detailed Description

This is a multicenter randomized, double-blind (subject, evaluator) placebo-controlled parallel-group clinical trial where 175 eligible subjects will be randomized into 1 of 4 groups (described below) using a 2:2:2:1 ratio. The purpose of the trial is to test the efficacy and comparative effectiveness of SGB and ketamine infusion on PTSD and post-traumatic headache. There are no reliably effective treatments for either PTSD or TBI-associated headaches, with preliminary and/or conflicting results suggesting efficacy for both SGB and ketamine for both conditions.

The first three groups will receive at least one intervention, with a smaller number receiving sham SGB/ placebo ketamine, which is necessary to determine efficacy and serve as a comparator. Several patient-reported outcomes, including quality of life measures, will be collected at baseline and the primary endpoint at 4 weeks. There will also be patient-reported outcome measures recorded at 1 and 2 weeks. Those with a positive categorical response (described under data collection) at 4 weeks will be followed further at 8 and 12 weeks. Those with negative outcomes will exit the study and be followed as an observational cohort where they will be eligible for non-study measures as determined by the treating providers. This may include other novel treatments such as using higher doses of ketamine, left-sided sympathetic blocks, sympathetic blocks with botulinum toxin and liposomal bupivacaine, and the use of neuromodulation.

For all patients who continue to experience a positive categorical outcome, unblinding will occur at 12 weeks, and they will be followed at 6 months as part of an observational cohort whereby the same outcome measures will be recorded. Those who exit the study and are unblinded at early time points (i.e., 4, 8 or 12 weeks in those with a 12-week negative outcome) will be followed as an observational cohort if they received one of the study treatments, including a variation (e.g., a higher dose of ketamine, a left-sided cervical sympathetic blocks). These time points will be the same as in the clinical trial portion of the study (1,2,4,8 and 12 weeks), and 6 months. For those in either the clinical trial extension or observational cohort who continue to experience a positive outcome at 6 months, we will again follow them at 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jordan Wood, BS; Phone Number: 312-695-0915; Email: jordan.wood1@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Anesthesiology Pain Medicine Center
      • Contact: Jordan Wood; Phone Number: 312-695-0915; Email: jordan.wood1@northwestern.edu
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Elsa Ermer, PhD; Phone Number: 301-550-0507; Email: crsr_research@usuhs.edu
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Not yet recruiting
      • Womack Army Medical Center
      • Contact: Min H Chang, MD; Phone Number: 910-643-2310; Email: min.h.chang.mil@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults 18 years or older
2. Stable doses of medications for > 2 weeks for TBI and/or PTSD
3. For TBI-associated headache with or without PTSD: HIT-6 score of >/=53. For PTSD with or without TBI-associated headache: PCL-5 score >/=33 OR. For those with TBI and PTSD, and a HIT-6 score < 53 and PCL-5 score of <33, individuals with a HIT-6 score of 50-52 and a PCL-5 score of 31 or 32 will be included.
4. Duration of chronic TBI or PTSD > 3 months

Exclusion Criteria:

1. Ketamine infusion or SGB within the past 6 months
2. Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)
3. Elevated intracranial pressure
4. For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)
5. Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)
6. Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)
7. Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)
8. Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A =Stellate ganglion block (SGB) with bupivacaine (LA) plus placebo ketamine (midazolam); Stellate ganglion block with the local anesthetic (LA) bupivacaine and placebo (1-7 mg midazolam + normal saline) ketamine. The stellate ganglion block will be performed with approximately 8 mL bupivacaine using ultrasound or fluoroscopic guidance. The placebo ketamine will consist of an initial 1-4 mg bolus of midazolam followed by boluses or an infusion (in normal saline) of midazolam up to 7 mg, over 30-60 minutes.	Procedure: Group A active comparator; Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion; Other Names: Group A
Active Comparator: Group B = Sham SGB plus ketamine infusion; Sham SGB will be 1-2 mL of saline given subcutaneously using ultrasound or fluoroscopic guidance. The ketamine will consist of Prior to the sham Stellate Ganglion Block procedure, the study drug ketamine or normal saline will be administered by one of the study team physicians. 100 ml bag will be administered by bolus/infusion or intermittent boluses up to 0.3 mg/kg). The ketamine infusion will start before the sham block where patients will be given 1-4 mg of midazolam + up to 0.3 mg/kg of ketamine, as bolus doses. Over the next 30-60 minutes patients will receive between 0.5-1 mg/kg total dose of ketamine, + additional midazolam as needed.	Drug: Group B active comparator; Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion; Other Names: Group B
Experimental: Group C = Stellate ganglion block (SGB) with bupivacaine LA plus ketamine infusion; These patients will receive both SGB with bupivacaine + ketamine as described above.	Combination product: Group C Experimental; Group C experimental Stellate Ganglion Block plus ketamine infusion; Other Names: Group C
Placebo Comparator: Group D = Sham SGB plus placebo ketamine (midazolam); These patients will receive the sham SGB + placebo ketamine as described above.	Other: Group D Placebo Comparator; Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline; Other Names: Group D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test (HIT-6)	Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.	4 weeks
PTSD Checklist (PCL-5)	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Sensitization Inventory (CSI)	A 25-item survey which measures central sensitization, scored from 0-100 with higher scores indicating greater sensitization sensitization. It is a self-reported tool that consists of statements related to current health symptoms rated on a 5-point Likert scale, with a score of 40 being the cut off value for central sensitization	4 weeks after procedure
Central Sensitization Inventory (CSI)	A 25-item survey which measures central sensitization, scored from 0-100 with higher scores indicating greater sensitization sensitization. It is a self-reported tool that consists of statements related to current health symptoms rated on a 5-point Likert scale, with a score of 40 being the cut off value for central sensitization	12 weeks after procedure
Headache intensity	Average and worst headache scores (0-10 numerical rating scale (NRS), overall pain (0=no pain, 10=worst pain imaginable). NRS scale)	4 weeks after procedure
Headache intensity	Average and worst headache scores (0-10 numerical rating scale (NRS), overall pain (0=no pain, 10=worst pain imaginable). NRS scale)	8 weeks after procedure
Headache intensity	Average and worst headache scores (0-10 numerical rating scale (NRS), overall pain (0=no pain, 10=worst pain imaginable). NRS scale)	12 weeks after procedure
Headache frequency	Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)	4 weeks after procedure
Headache frequency	Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)	8 weeks after procedure
Analgesic or psychotropic medication reduction	An analgesic or psychotropic medication reduction identified as a > 20% reduction in opioid, barbiturate or benzodiazepine, or cessation of nonopioid analgesic, or > 50% reduction in non-benzodiazepine sedation or psychotropic medication (e.g., antidepressant or antipsychotic).	4 weeks after procedure
Analgesic or psychotropic medication reduction	An analgesic or psychotropic medication reduction identified as a > 20% reduction in opioid, barbiturate or benzodiazepine, or cessation of nonopioid analgesic, or > 50% reduction in non-benzodiazepine sedation or psychotropic medication (e.g., antidepressant or antipsychotic).	8 weeks after procedure
Analgesic or psychotropic medication reduction	An analgesic or psychotropic medication reduction identified as a > 20% reduction in opioid, barbiturate or benzodiazepine, or cessation of nonopioid analgesic, or > 50% reduction in non-benzodiazepine sedation or psychotropic medication (e.g., antidepressant or antipsychotic).	12 weeks after procedure
Headache Impact Test (HIT-6)	Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.	8 weeks
Headache Impact Test (HIT-6)	Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.	12 weeks
Quality of Life after Brain Injury scale (QoLIBRI)	37-item scale with questions ranging from 1 (not at all) to 5 (very true), with a score ranging from 0-100 (higher numbers indicate better quality of life) calculated from the mean score minus 1, multiplied by 4.	4 weeks
Quality of Life after Brain Injury scale (QoLIBRI)	37-item scale with questions ranging from 1 (not at all) to 5 (very true), with a score ranging from 0-100 (higher numbers indicate better quality of life) calculated from the mean score minus 1, multiplied by 4.	8 weeks
Quality of Life after Brain Injury scale (QoLIBRI)	37-item scale with questions ranging from 1 (not at all) to 5 (very true), with a score ranging from 0-100 (higher numbers indicate better quality of life) calculated from the mean score minus 1, multiplied by 4.	12 weeks
Hospital Anxiety and Depression Scale (HADS)	14-item instrument with questions assessing anxiety and depression (7 each) scored from 0-3. For each subscale (anxiety and depression), scores range from 0-21, with higher scores indicating greater pathology.	4 weeks
Hospital Anxiety and Depression Scale (HADS)	14-item instrument with questions assessing anxiety and depression (7 each) scored from 0-3. For each subscale (anxiety and depression), scores range from 0-21, with higher scores indicating greater pathology.	8 weeks
Hospital Anxiety and Depression Scale (HADS)	14-item instrument with questions assessing anxiety and depression (7 each) scored from 0-3. For each subscale (anxiety and depression), scores range from 0-21, with higher scores indicating greater pathology.	12 weeks
Patient Global Impression of Change Scale	7-item Likert scale with scores ranging from 0 (worse or no change) to 7 (a great deal better)	4 weeks
Patient Global Impression of Change Scale	7-item Likert scale with scores ranging from 0 (worse or no change) to 7 (a great deal better)	8 weeks
Patient Global Impression of Change Scale	7-item Likert scale with scores ranging from 0 (worse or no change) to 7 (a great deal better)	12 weeks
Positive categorical outcome	Positive is >/= 4 on the PGIC scale and >/= 6-point reduction in HIT-6 and/or a >/= 10-point reduction in PCL-5.	4 weeks
Positive categorical outcome	Positive is >/= 4 on the PGIC scale and >/= 6-point reduction in HIT-6 and/or a >/= 10-point reduction in PCL-5.	8 weeks
Positive categorical outcome	Positive is >/= 4 on the PGIC scale and >/= 6-point reduction in HIT-6 and/or a >/= 10-point reduction in PCL-5.	12 weeks
Sheehan Suicidality Tracking Scale (S-STS)	The S-STS is a short scale designed to assess and monitor suicidality over time and is very sensitive to changes in treatment. The survey has 8 questions with each scored from none (0) to extremely (4). outcomes.	4 weeks after procedure
International Trauma Questionnaire	18-question survey that measures the impact PTSD has on an individual, and helps phenotype PTSD (i.e., into complex PTSD or non-complex). Each question is scored from 0-4 (range 0-72), with higher scores indicating greater disease burden.	4 weeks
International Trauma Questionnaire	18-question survey that measures the impact PTSD has on an individual, and helps phenotype PTSD (i.e., into complex PTSD or non-complex). Each question is scored from 0-4 (range 0-72), with higher scores indicating greater disease burden.	12 weeks
Central Sensitization Inventory (CSI)	A 25-item survey which measures central sensitization, scored from 0-100 with higher scores indicating greater sensitization sensitization. It is a self-reported tool that consists of statements related to current health symptoms rated on a 5-point Likert scale, with a score of 40 being the cut off value for central sensitization	1 week after procedure
Central Sensitization Inventory (CSI)	A 25-item survey which measures central sensitization (amplified nervous system response to sensory stimuli), scored from 0-100 with higher scores indicating greater sensitization sensitization. It is a self-reported tool that consists of statements related to current health symptoms rated on a 5-point Likert scale, with a score of 40 being the cut off value for central sensitization	2 weeks after procedure
Central Sensitization Inventory (CSI)	A 25-item survey which measures central sensitization, scored from 0-100 with higher scores indicating greater sensitization sensitization. It is a self-reported tool that consists of statements related to current health symptoms rated on a 5-point Likert scale, with a score of 40 being the cut off value for central sensitization	8 weeks after procedure
Headache intensity	Average and worst headache scores (0-10 numerical rating scale (NRS), overall pain (0=no pain, 10=worst pain imaginable). NRS scale)	1 week after procedure
Headache intensity	Average and worst headache scores (0-10 numerical rating scale (NRS), overall pain (0=no pain, 10=worst pain imaginable). NRS scale)	2 weeks after procedure
Headache frequency	Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)	1 week after procedure
Headache frequency	Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)	2 weeks after procedure
Headache frequency	Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)	12 weeks after procedure
Analgesic or psychotropic medication reduction	An analgesic or psychotropic medication reduction identified as a > 20% reduction in opioid, barbiturate or benzodiazepine, or cessation of nonopioid analgesic, or > 50% reduction in non-benzodiazepine sedation or psychotropic medication (e.g., antidepressant or antipsychotic).	1 week after procedure
Analgesic or psychotropic medication reduction	An analgesic or psychotropic medication reduction identified as a > 20% reduction in opioid, barbiturate or benzodiazepine, or cessation of nonopioid analgesic, or > 50% reduction in non-benzodiazepine sedation or psychotropic medication (e.g., antidepressant or antipsychotic).	2 weeks after procedure
Headache Impact Test (HIT-6)	Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.	1 week
Headache Impact Test (HIT-6)	Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.	2 weeks
Quality of Life after Brain Injury scale (QoLIBRI)	37-item scale with questions ranging from 1 (not at all) to 5 (very true), with a score ranging from 0-100 (higher numbers indicate better quality of life) calculated from the mean score minus 1, multiplied by 4.	1 week
Quality of Life after Brain Injury scale (QoLIBRI)	37-item scale with questions ranging from 1 (not at all) to 5 (very true), with a score ranging from 0-100 (higher numbers indicate better quality of life) calculated from the mean score minus 1, multiplied by 4.	2 weeks
Hospital Anxiety and Depression Scale (HADS)	14-item instrument with questions assessing anxiety and depression (7 each) scored from 0-3. For each subscale (anxiety and depression), scores range from 0-21, with higher scores indicating greater pathology.	1 week
Hospital Anxiety and Depression Scale (HADS)	Hospital anxiety and depression scale, a 14 question survey scored survey. The anxiety is scored 0 (low) to 21 (high). The depression is scored 0 (low) to 21 (high).	2 weeks after procedure
Patient Global Impression of Change Scale	7-item Likert scale with scores ranging from 0 (worse or no change) to 7 (a great deal better)	1 week
Patient Global Impression of Change Scale	7-item Likert scale with scores ranging from 0 (worse or no change) to 7 (a great deal better)	2 weeks
Positive categorical outcome	Positive is >/= 4 on the PGIC scale and >/= 6-point reduction in HIT-6 and/or a >/= 10-point reduction in PCL-5.	1 week
Positive categorical outcome	Positive is >/= 4 on the PGIC scale and >/= 6-point reduction in HIT-6 and/or a >/= 10-point reduction in PCL-5.	2 weeks
PCL-5	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	1 week
PCL-5	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	2 weeks
PCL-5	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	8 weeks
PCL-5	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	12 weeks
PTSD Checklist (PCL-5)	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	1 week
PTSD Checklist (PCL-5)	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	2 weeks
PTSD Checklist (PCL-5)	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	8 weeks
PTSD Checklist (PCL-5)	PTSD Checklist (PCL-5) is a psychometrically-validated 20-item instrument that measures the quality of life in people with posttraumatic stress disorder (PTSD_, scored from 0-80 with higher scores indicating greater disability assesses 20 DSM-5 symptoms of posttraumatic stress disorder.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative sensory testing	Quantitative sensory testing will include mechanical temporal summation, a measure of central sensitization, pressure pain thresholds, and the simultaneous presentation of 2 stimuli to assess intrinsic modulation, known as conditioned pain modulation. This test is optional	4 weeks after procedure
Serum biomarkers	Markers of inflammation to include interleukins 1 and 6 (IL1 and 6), tumor necrosis factor-alpha (TNF), C-reactive protein (CRP), nerve growth factor (NGF), brain-derived neutrotrophic factor (BDNF), Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP). This test is optional.	4 weeks after procedure
Structural MRI Imaging	Volumetric changes in gray and white matter, in different regions. This test is optional.	4 weeks after procedure
Functional MRI	Functional changes in pain and emotion processing centers (e.g., activation of brainstem, thalamus, hippocampus, insula, anterior cingulate, and somatosensory cortices) as well as changes in connectivity between regions. This test is optional.	4 weeks after procedure

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Walter Reed National Military Medical Center; Lviv National Medical University; Womack Army Medical Center
• Investigators: Principal Investigator: Steven Cohen, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ketamine; Stellate Ganglion Block
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Headache Disorders; Stress Disorders, Traumatic; Headache Disorders, Secondary; Stress Disorders, Post-Traumatic; Post-Traumatic Headache
• Other Study ID Numbers: STU00221519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No