Clinical trial NCT05855876: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Traumatic Stress Disorder
Traumatic Brain Injury
Lead sponsor: Stella Center
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change from baseline in Epigenetic Aging at 15 days
timeFrame: day 15
measure: Change from baseline in Epigenetic Aging at 90 days
timeFrame: day 90
measure: Change from baseline in Epigenetic Aging at 180 days
timeFrame: day 180
Secondary outcomes:
measure: Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 15 days
timeFrame: day 15
measure: Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days
timeFrame: day 90
measure: Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 180 days
timeFrame: day 180
measure: Change from baseline in Depression at 15 days
timeFrame: day 15
measure: Change from baseline in Depression at 90 days
timeFrame: day 90
measure: Change from baseline in Depression at 180 days
timeFrame: day 180
measure: Change from baseline in Suicidal Ideation at 15 days
timeFrame: day 15
measure: Change from baseline in Suicidal Ideation at 90 days
timeFrame: day 90
measure: Change from baseline in Suicidal Ideation at 180 days
timeFrame: day 180
measure: Change from baseline in Anxiety at 15 days
timeFrame: day 15
measure: Change from baseline in Anxiety at 90 days
timeFrame: day 90
measure: Change from baseline in Anxiety at 180 days
timeFrame: day 180
measure: Change from baseline in Post-Concussion Symptom Severity at 15 days
timeFrame: day 15
measure: Change from baseline in Post-Concussion Symptom Severity at 90 days
timeFrame: day 90
measure: Change from baseline in Post-Concussion Symptom Severity at 180 days
timeFrame: day 180
measure: Change from baseline in Free testosterone levels at 15 days
timeFrame: day 15
measure: Change from baseline in Free testosterone levels at 90 days
timeFrame: day 90
measure: Change from baseline in Free testosterone levels at 180 days
timeFrame: day 180
measure: Change from baseline in C-reactive protein (CRP) levels at 15 days
timeFrame: day 15
measure: Change from baseline in C-reactive protein (CRP) levels at 90 days
timeFrame: day 90
measure: Change from baseline in C-reactive protein (CRP) levels at 180 days
timeFrame: day 180
Other outcomes:
Locations:
city: Westmont
country: United States
facility: Stella Center
state: Illinois
Study officials:
affiliation: Stella Center
name: Eugene Lipov, MD
role: PRINCIPAL_INVESTIGATOR
References: