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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Anesthesiology Pain Medicine Center
RECRUITING
Chicago
Maryland
Walter Reed National Military Medical Center
NOT_YET_RECRUITING
Bethesda
North Carolina
Womack Army Medical Center
NOT_YET_RECRUITING
Fort Bragg
Contact Information
Primary
Paul Fitzgerald, RN,BSN,MS
p-fitzgerald2@northwestern.edu
312-695-1064
Time Frame
Start Date:2025-07-02
Estimated Completion Date:2028-04-30
Participants
Target number of participants:175
Treatments
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.
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.
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.
Placebo_comparator: Group D = Sham SGB plus placebo ketamine (midazolam)
These patients will receive the sham SGB + placebo ketamine as described above.