Ketamine and SGB for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySteven Cohen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with PTSD and TBI-related headaches, common in military personnel from recent conflicts. Participants should have these conditions to qualify but the full inclusion and exclusion criteria are not provided here.

Inclusion Criteria

I am 18 years old or older.

My medication doses for TBI or PTSD have been stable for more than 2 weeks.

I have severe headaches or PTSD with specific test scores.

+1 more

Exclusion Criteria

I do not have conditions like dementia or Parkinson's affecting my thinking.

I do not have active psychosis or unmanaged mental health conditions like bipolar disorder.

I do not have any health conditions that could worsen with treatment.

+5 more

Participant Groups

The study tests if a nerve block procedure (SGB) or ketamine medication, alone or combined, can relieve PTSD and headache symptoms from TBI. It's a randomized, double-blind, placebo-controlled trial across multiple centers.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Group C = Stellate ganglion block (SGB) with bupivacaine LA plus ketamine infusionExperimental Treatment1 Intervention

These patients will receive both SGB with bupivacaine + ketamine as described above.

Group II: Group A =Stellate ganglion block (SGB) with bupivacaine (LA) plus placebo ketamine (midazolam)Active Control1 Intervention

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 III: Group B = Sham SGB plus ketamine infusionActive Control1 Intervention

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 IV: Group D = Sham SGB plus placebo ketamine (midazolam)Placebo Group1 Intervention

These patients will receive the sham SGB + placebo ketamine as described above.