Posttraumatic HeadachePhase 2NCT06608277
Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD
A Phase 2 study testing Group A active comparator, Group B active comparator and Group C Experimental in people with Posttraumatic Headache and Posttraumatic Stress Disorder, run by Northwestern University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Headache, Posttraumatic Stress Disorder
- What is being tested?
- Group A active comparator, Group B active comparator and Group C Experimental
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jul 2025to 30 Apr 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Stable doses of medications for > 2 weeks for TBI and/or PTSD
- 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.
- Duration of chronic TBI or PTSD > 3 months
Who cannot join
- Ketamine infusion or SGB within the past 6 months
- Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)
- Elevated intracranial pressure
- For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)
- Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)
- Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)
- Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)
- Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Elsa Ermer, PhD, 301-550-0507, crsr_research@usuhs.edu
- Recruiting
Anesthesiology Pain Medicine Center
Chicago, Illinois, 60611
Jordan Wood, 312-695-0915, jordan.wood1@northwestern.edu
- Not yet recruiting
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
Min H Chang, MD, 910-643-2310, min.h.chang.mil@health.mil
About this study
Official title: 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:
Read more
- To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache;
- To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD;
- To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD;
- 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;
- Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
Secondary Objectives:
- 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).
- Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
Read the 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.
- Being tested
- Group A active comparator, Group B active comparator, Group C Experimental, Group D Placebo Comparator
- Keywords
- Ketamine, Stellate Ganglion Block
- Medical subject headings
- Post-Traumatic Headache, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A active comparatorProcedure or surgery
Also called Group A
Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion
Group B active comparatorDrug
Also called Group B
Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion
Group C ExperimentalCombination product
Also called Group C
Group C experimental Stellate Ganglion Block plus ketamine infusion
Group D Placebo ComparatorOther
Also called Group D
Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group A =Stellate ganglion block (SGB) with bupivacaine (LA) plus placebo ketamine (midazolam) | Active comparator | 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. Receives: Procedure: Group A active comparator |
| Group B = Sham SGB plus ketamine infusion | Active comparator | 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. Receives: Drug: Group B active comparator |
| Group C = Stellate ganglion block (SGB) with bupivacaine LA plus ketamine infusion | Experimental | These patients will receive both SGB with bupivacaine + ketamine as described above. Receives: Combination Product: Group C Experimental |
| Group D = Sham SGB plus placebo ketamine (midazolam) | Placebo comparator | These patients will receive the sham SGB + placebo ketamine as described above. Receives: Other: Group D Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (55)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 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
Measured: 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)
Measured: 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)
Measured: 2 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 weeks after procedure
Headache frequency
Days per week with scores greater or equal to 2, and 7/10 (2= mild headache, 7=severe headache)
Measured: 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).
Measured: 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).
Measured: 2 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 2 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 weeks after procedure
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 2 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start2 Jul 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic HeadacheStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Lviv National Medical University, Womack Army Medical Center
- Responsible party
- Principal investigator, Steven Cohen, Northwestern University
- Investigators
- Steven Cohen, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608277
- Sponsor's protocol ID
- STU00221519
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cohen SP, Smolynets R, Wood J, Singh V, Gelfand HJ, Park EJ, Rodriguez SE, Harcum S, Ermer E, Dodd LD, King DB, Ross J, Khan D, Nader AM, Pasquina PF, Brody DL. Multi-center, randomized controlled efficacy and comparative-effectiveness study evaluating ketamine, stellate ganglion blocks, combination treatment, and sham treatments for posttraumatic stress disorder and traumatic brain injury-associated headache: a study protocol. Pain Manag. 2026 Oct 1:1-11. doi: 10.1080/17581869.2026.2738419. Online ahead of print.
PubMed 42817839