Recruiting
Phase 2

SGB & Ketamine

Sponsor:

Northwestern University

Code:

NCT06608277

Conditions

Posttraumatic Headache

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group A active comparator

Group B active comparator

Group C Experimental

Group D Placebo Comparator

Study Details

Brief summary:

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.

Conditions

Posttraumatic Headache

Posttraumatic Stress Disorder

Study ID

NCT06608277

Start date

Jul 2, 2025

Status verified date

Apr, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults 18 years or older
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:

1. Ketamine infusion or SGB within the past 6 months
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)

Study Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Headache Impact Test (HIT-6) [ Time Frame: 4 weeks ]
  • PTSD Checklist (PCL-5) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jordan Wood, BS

312-695-0915jordan.wood1@northwestern.edu

Locations

Anesthesiology Pain Medicine Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jordan Wood

312-695-0915jordan.wood1@northwestern.edu

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Elsa Ermer, PhD

301-550-0507crsr_research@usuhs.edu

More Information

Sponsor

Northwestern University

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Ketamine
  • Stellate Ganglion Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-01.