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

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

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Post-Traumatic Stress Disorder
• Intervention / Treatment: Procedure: subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Westmont, Illinois, United States, 60656
      • Recruiting
      • Stella Center
      • Contact: Eugene Lipov, MD; Phone Number: 773-992-1349; Email: hope4ptsi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include 20 individuals, recruited from SOF with an active duty history of at least 5 years. Subjects may be in active duty or retired, male and female, between the ages of 40 and 60 years old. The participants must have a confirmed diagnosis of PTSD.

Description

Inclusion Criteria:

• Recruited from SOF with an active duty history of at least 5 years.
• Subjects may be in active duty or retired, male and female, between the ages of 40 and 60 years old.
• The participants must have a confirmed diagnosis of PTSD, identified by Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores higher than 40.
• The participants must have been on a stable pharmacological or psychotherapeutic therapy for at least three months (if applicable), and continue this treatment throughout the duration of the study.
• They must be able and willing to consent for the study. Individuals who are able to become pregnant must adhere to a medically accepted method of contraception (eg. hormonal birth control, barrier birth control, intrauterine device, abstinence).

Exclusion Criteria:

• Existing Horner syndrome;
• Allergy to local anesthetics or contrast;
• Previous history of stellate ganglion block with psychosis;
• Admission to in-patient psychiatric facility within last 3 months;
• History of moderate of severe TBI;
• Currently pregnant or breastfeeding;
• Current substance use disorder, or test positive for 1 or more illegal or controlled drugs on the initial urine drug screen, such as cocaine, marijuana, amphetamines, opioids, benzodiazepines, amongst others;
• Previous behavioral health diagnoses (bipolar I, psychosis, etc);
• Currently undergoing exposure therapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Epigenetic Aging at 15 days	GrimAge epigenetic clock tool to assess DNA methylation	day 15
Change from baseline in Epigenetic Aging at 90 days	GrimAge epigenetic clock tool to assess DNA methylation	day 90
Change from baseline in Epigenetic Aging at 180 days	GrimAge epigenetic clock tool to assess DNA methylation	day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 15 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 15
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 90
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 180 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 180
Change from baseline in Depression at 15 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 15
Change from baseline in Depression at 90 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 90
Change from baseline in Depression at 180 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 180
Change from baseline in Suicidal Ideation at 15 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 15
Change from baseline in Suicidal Ideation at 90 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 90
Change from baseline in Suicidal Ideation at 180 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 180
Change from baseline in Anxiety at 15 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 15
Change from baseline in Anxiety at 90 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 90
Change from baseline in Anxiety at 180 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 180
Change from baseline in Post-Concussion Symptom Severity at 15 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 15
Change from baseline in Post-Concussion Symptom Severity at 90 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 90
Change from baseline in Post-Concussion Symptom Severity at 180 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 180
Change from baseline in Free testosterone levels at 15 days	Quest diagnostics to measure Free testosterone levels	day 15
Change from baseline in Free testosterone levels at 90 days	Quest diagnostics to measure Free testosterone levels	day 90
Change from baseline in Free testosterone levels at 180 days	Quest diagnostics to measure Free testosterone levels	day 180
Change from baseline in C-reactive protein (CRP) levels at 15 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 15
Change from baseline in C-reactive protein (CRP) levels at 90 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 90
Change from baseline in C-reactive protein (CRP) levels at 180 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 180

Collaborators and Investigators

• Sponsor: Stella Center
• Investigators: Principal Investigator: Eugene Lipov, MD, Stella Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): April 5, 2024
• Study Completion (Estimated): April 5, 2024

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: ROBRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No