NCT05855876

Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Stella Center · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.

Detailed description

The primary objective of this study is to assess the impact of a combined protocol of subanesthetic ketamine infusions (SKI) and bilateral cervical sympathetic blocks (CSB) on aging, as measured by the GrimAge epigenetic clock. The secondary objective of this study is to assess the impact of this treatment paradigm on PTSD and mental health, as measured over a 6 month time period using the following questionnaires: Post-traumatic Stress Disorder Checklist (PCL-5), Patient Health Questionnaire 9 (PHQ-9), Depressive Symptom Index-Suicidality Subscale (DSI-SS), Generalized Anxiety Disorder 7-item (GAD-7), and Neurobehavioral Symptom Inventory (NSI). The tertiary objectives of the study are to investigate if PTSD is associated with significantly reduced free testosterone levels and increased C-reactive protein (CRP) levels.

Conditions

• Post-Traumatic Stress Disorder
• Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	subanesthetic ketamine infusions and bilateral cervical sympathetic blocks	Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Timeline

• Start date: 2023-07-05
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2023-05-12
• Last updated: 2023-07-17

Locations

1 site across 1 country: United States