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

Tracking Information

• First Submitted Date: April 21, 2023
• First Posted Date: May 12, 2023
• Last Update Posted Date: July 17, 2023
• Actual Study Start Date: July 5, 2023
• Estimated Primary Completion Date: April 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Change from baseline in Free testosterone levels at 15 days [ Time Frame: day 15 ]
  Quest diagnostics to measure Free testosterone levels
• Change from baseline in Free testosterone levels at 90 days [ Time Frame: day 90 ]
  Quest diagnostics to measure Free testosterone levels
• Change from baseline in Free testosterone levels at 180 days [ Time Frame: day 180 ]
  Quest diagnostics to measure Free testosterone levels
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
• Official Title: Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
• Brief 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Post-Traumatic Stress Disorder
• Traumatic Brain Injury

Intervention

Procedure: subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 2, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 5, 2024
• Estimated Primary Completion Date: April 5, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05855876
• Other Study ID Numbers: ROBRA
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eugene Lipov, Stella Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Stella Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eugene Lipov, MD; Stella Center

• PRS Account: Stella Center
• Verification Date: July 2023