Reversal of Battle-Related Aging (ROBRA) in a... — Clinical Trial Details

The primary objective is to assess the impact of combined subanesthetic ketamine infusions and bilateral cervical sympathetic blocks on biological aging measured by the GrimAge epigenetic clock in SOF members with PTSD/TBI.

Secondary outcomes include changes in PTSD and mental health over six months using PCL-5, PHQ-9, DSI-SS, GAD-7, and NSI; tertiary objectives examine associations with free testosterone and C-reactive protein.

Prospective observational cohort of 20 SOF participants recruited at the Stella Center with clinical and biomarker assessments before and after the combined intervention protocol.

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.

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

Detailed Description

Study Arms & Interventions

SKI + CSB

Interventions

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Inclusion Criteria

Exclusion Criteria

Study Details

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