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Combination Treatment

Ketamine and SGB for Traumatic Brain Injury

Phase 2

Waitlist Available

Led By Steven Cohen, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Duration of chronic TBI or PTSD > 3 months

Be older than 18 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

"This trial aims to see if a procedure called stellate ganglion block (SGB), medication (ketamine), or a combination of both can help alleviate PTSD and traumatic brain injury (TBI

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, generally ketamine may cause dizziness, nausea, increased blood pressure and dissociation; SGB could potentially lead to temporary soreness or bruising at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had TBI or PTSD for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have high pressure inside my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Checklist (PCL-5)

Secondary study objectives

Analgesic or psychotropic medication reduction

Central Sensitization Inventory (CSI)

Headache Impact Test (HIT-6)

+7 more

Other study objectives

Quantitative sensory testing

Serum biomarkers

Trial Design

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.

0 / 4Eligibility criteria met