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NCT06608277 · ClinicalTrials.gov registry record · Phase 2
Ketamine, SGB and Combination Treatment for TBI
A Phase 2 study of Posttraumatic Stress Disorder and Posttraumatic Headache, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 3
- Study locations
NCT06608277 is a Phase 2 study of Posttraumatic Stress Disorder and Posttraumatic Headache that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 175 participants, above the 110-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (59% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT06608277, a Phase 2 study of Posttraumatic Stress Disorder and Posttraumatic 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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2025-07-02 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06608277
The ClinicalTrials.gov registry entry for NCT06608277 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (59% higher). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 4 interventions - of which Group A active comparator is the first listed.
NCT06608277 reports 3 study locations spanning 3 distinct geographic areas - top geographies include 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: Posttraumatic Stress Disorder, Posttraumatic 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.
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