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

Stella Center

Status: Enrolling

Conditions: Traumatic Brain Injury; Post-Traumatic Stress Disorder

Treatments: Procedure: subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Study type: Observational

Funder types: Other

Identifiers

NCT05855876

ROBRA

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.