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NCT06608277 · ClinicalTrials.gov registry record · Phase 2

Ketamine, SGB and Combination Treatment for TBI

A Phase 2 study of Post Traumatic Stress Disorder and Post-Traumatic Headache, sponsored by Northwestern University.

Recruiting
Registry status
Phase 2
Development phase
175
Enrollment target
3
Study locations

NCT06608277: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Post-Traumatic Headache, sponsored by Northwestern University.

NCT06608277 is a Phase 2 study of Post Traumatic Stress Disorder and Post-Traumatic Headache that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 175 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06608277, a Phase 2 study of Post Traumatic Stress Disorder and Post-Traumatic Headache, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
Phase 2
Development phase
175 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

Headache Impact Test (HIT-6) is a 6-item instrument that measures the impact of headaches, scored from 36-78 with higher scores indicating greater disability impact of headaches in a 1-month period that has been validated for a variety of headache conditions, including tension-type headache and migraine.

Conditions Studied

Post Traumatic Stress Disorder Post-Traumatic Headache

Interventions

  • PROCEDURE Group A active comparator
  • DRUG Group B active comparator
  • COMBINATION_PRODUCT Group C Experimental
  • OTHER Group D Placebo Comparator

Study Locations (3)

Illinois

  • Anesthesiology Pain Medicine Center - Chicago

Maryland

  • Walter Reed National Military Medical Center - Bethesda

North Carolina

  • Womack Army Medical Center - Fort Bragg

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2025-07-02
Est. Completion 2028-04-30
Phase Phase 2
Northwestern University

1,209 total trials

What NCT06608277 shows while recruiting

NCT06608277 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (74% lower).

The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 4 interventions - of which Group A active comparator is the first listed.

NCT06608277 reports a single indexed study location in Illinois, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06608277 about?

NCT06608277 is a clinical study titled "Ketamine, SGB and Combination Treatment for TBI". 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 wheth...

What is the current status of trial NCT06608277?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2025-07-02. Estimated completion is 2028-04-30.

What conditions does trial NCT06608277 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Post-Traumatic Headache.

What interventions are being tested in trial NCT06608277?

The interventions under investigation include: Group A active comparator (PROCEDURE), Group B active comparator (DRUG), Group C Experimental (COMBINATION_PRODUCT), Group D Placebo Comparator (OTHER).

Who is sponsoring clinical trial NCT06608277?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06608277 being conducted?

This trial has 3 study locations across Illinois, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06608277's enrollment target sits among peer trials

175 68th of 262 higher than 194 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06608277

Source: ClinicalTrials.gov NCT06608277, the US trial registry maintained by the National Library of Medicine. NCT06608277 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.