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

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

Interventions

PROCEDURE

Group A active comparator

Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion

DRUG

Group B active comparator

Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion

COMBINATION_PRODUCT

Group C Experimental

Group C experimental Stellate Ganglion Block plus ketamine infusion

OTHER

Group D Placebo Comparator

Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline

Sponsors & Collaborators

• Walter Reed National Military Medical Center

  collaborator FED

• Lviv National Medical University

  collaborator OTHER

• Womack Army Medical Center

  collaborator FED

• Northwestern University

  lead OTHER

Principal Investigators

• Steven Cohen, MD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-02

Primary Completion

2027-12-30

Completion

2028-04-30

FDA Drug

Yes

Countries

• United States

Study Locations