Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
175 participants
INTERVENTIONAL
2025-07-02
2028-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Group A active comparator
Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion
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.
Group B active comparator
Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion
Group C = Stellate ganglion block (SGB) with bupivacaine LA plus ketamine infusion
These patients will receive both SGB with bupivacaine + ketamine as described above.
Group C Experimental
Group C experimental Stellate Ganglion Block plus ketamine infusion
Group D = Sham SGB plus placebo ketamine (midazolam)
These patients will receive the sham SGB + placebo ketamine as described above.
Group D Placebo Comparator
Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline
Interventions
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Group A active comparator
Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion
Group B active comparator
Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion
Group C Experimental
Group C experimental Stellate Ganglion Block plus ketamine infusion
Group D Placebo Comparator
Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Walter Reed National Military Medical Center
FED
Lviv National Medical University
OTHER
Womack Army Medical Center
FED
Northwestern University
OTHER
Responsible Party
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Steven Cohen
Principal Investigator
Principal Investigators
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Steven Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Anesthesiology Pain Medicine Center
Chicago, Illinois, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00221519
Identifier Type: -
Identifier Source: org_study_id
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