Examining aging reversal in special operations forces with PTSD and TBI
Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
This study is testing if a new treatment combining ketamine and nerve blocks can help Special Operations Forces members with PTSD and brain injuries feel better and possibly reverse some signs of aging.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Stella Center Academic / other |
| Locations | 1 site (Westmont, Illinois) |
| Trial ID | NCT05855876 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of a combined treatment protocol involving subanesthetic ketamine infusions and bilateral cervical sympathetic blocks on aging markers in Special Operations Forces members diagnosed with PTSD and traumatic brain injury. The primary focus is to measure changes in the GrimAge epigenetic clock, while secondary objectives include assessing improvements in mental health through various standardized questionnaires over a six-month period. Additionally, the study will explore the relationship between PTSD and hormonal changes, specifically testosterone and C-reactive protein levels.
Who should consider this trial
Good fit: Ideal candidates are active duty or retired Special Operations Forces members aged 40 to 60 with a confirmed diagnosis of PTSD.
Not a fit: Patients with conditions such as Horner syndrome or those with a history of severe psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into innovative treatments that may reverse aging effects and improve mental health in veterans with PTSD and TBI.
How similar studies have performed: While the specific combination of treatments is novel, similar studies have shown promising results in using ketamine for PTSD and mental health improvements.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Westmont, Illinois
- Stella Center — Westmont, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Eugene Lipov, MD — Stella Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.