Recruiting

ROBRA

Sponsor:

Stella Center

Code:

NCT05855876

Conditions

Post-Traumatic Stress Disorder

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Study Details

Brief summary:

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

Conditions

Post-Traumatic Stress Disorder

Traumatic Brain Injury

Study ID

NCT05855876

Start date

Jul 5, 2023

Status verified date

Jul, 2023

Completion date

Apr 5, 2024

Anticipated

Primary completion date

Apr 5, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Primary outcome measure

  • Change from baseline in Epigenetic Aging at 15 days [ Time Frame: day 15 ]
  • Change from baseline in Epigenetic Aging at 90 days [ Time Frame: day 90 ]
  • Change from baseline in Epigenetic Aging at 180 days [ Time Frame: day 180 ]

Central Contacts and Locations

Locations

Stella Center

Recruiting

Westmont, Illinois, United States, 60656

Contacts

Eugene Lipov, MD

773-992-1349hope4ptsi@gmail.com

More Information

Sponsor

Stella Center

Last update posted

Jul 17, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stella Center on 2023-07-17.