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

Conditions

• Posttraumatic Headache
• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Group A active comparator — PROCEDURE
  Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion
• Group B active comparator — DRUG
  Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion
• Group C Experimental — COMBINATION_PRODUCT
  Group C experimental Stellate Ganglion Block plus ketamine infusion
• Group D Placebo Comparator — OTHER
  Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline

Study Details

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.

Key Dates

Start date

Jul 2, 2025

Status verified

Apr 2026

Primary completion

Dec 30, 2027

Completion

Apr 30, 2028

Study Design

Enrollment

175 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Headache Impact Test (HIT-6) [ Time Frame: 4 weeks ]

Central Contacts

• Jordan Wood, BS
  312-695-0915
  [email protected]

Locations (3)

Find similar trials in Chicago, IL

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