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

• ClinicalTrials.gov Identifier: NCT05855876
• Recruitment Status: Recruiting
• First Posted: May 12, 2023
• Last Update Posted: July 17, 2023
• Sponsor: Stella Center
• Information provided by (Responsible Party): Eugene Lipov, Stella Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Post-Traumatic Stress Disorder; Traumatic Brain Injury	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 Design

• Study Type: Observational
• Estimated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
• Actual Study Start Date: July 5, 2023
• Estimated Primary Completion Date: April 5, 2024
• Estimated Study Completion Date: April 5, 2024

Groups and Cohorts

Intervention Details:

• Procedure: subanesthetic ketamine infusions and bilateral cervical sympathetic blocks
  Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in Epigenetic Aging at 15 days [ Time Frame: day 15 ]
   GrimAge epigenetic clock tool to assess DNA methylation
2. Change from baseline in Epigenetic Aging at 90 days [ Time Frame: day 90 ]
   GrimAge epigenetic clock tool to assess DNA methylation
3. Change from baseline in Epigenetic Aging at 180 days [ Time Frame: day 180 ]
   GrimAge epigenetic clock tool to assess DNA methylation

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Stella Center; Recruiting

Westmont, Illinois, United States, 60656

Contact: Eugene Lipov, MD 773-992-1349 hope4ptsi@gmail.com

Sponsors and Collaborators

Stella Center

Investigators

• Principal Investigator: Eugene Lipov, MD; Stella Center

More Information

• Responsible Party: Eugene Lipov, Principal Investigator, Stella Center
• ClinicalTrials.gov Identifier: NCT05855876
• Other Study ID Numbers: ROBRA
• First Posted: May 12, 2023
• Last Update Posted: July 17, 2023
• Last Verified: July 2023

• 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

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Trauma and Stressor Related Disorders; Mental Disorders; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action