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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855876
• Other study ID #: ROBRA
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: April 5, 2024

Study information

• Verified date: July 2023
• Source: Stella Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

Procedure:
• subanesthetic ketamine infusions and bilateral cervical sympathetic blocks
Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks

Locations

Country	Name	City	State
United States	Stella Center	Westmont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Stella Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Epigenetic Aging at 15 days	GrimAge epigenetic clock tool to assess DNA methylation	day 15
Primary	Change from baseline in Epigenetic Aging at 90 days	GrimAge epigenetic clock tool to assess DNA methylation	day 90
Primary	Change from baseline in Epigenetic Aging at 180 days	GrimAge epigenetic clock tool to assess DNA methylation	day 180
Secondary	Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 15 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 15
Secondary	Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 90
Secondary	Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 180 days	Post-traumatic Stress Disorder Checklist (PCL-5), a 20-item self-report measure yielding a total symptom severity score between 0 and 80.	day 180
Secondary	Change from baseline in Depression at 15 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 15
Secondary	Change from baseline in Depression at 90 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 90
Secondary	Change from baseline in Depression at 180 days	Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report measure yielding a depression severity score between 0 and 27.	day 180
Secondary	Change from baseline in Suicidal Ideation at 15 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 15
Secondary	Change from baseline in Suicidal Ideation at 90 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 90
Secondary	Change from baseline in Suicidal Ideation at 180 days	Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure yielding a suicidal ideation severity score between 0 and 12.	day 180
Secondary	Change from baseline in Anxiety at 15 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 15
Secondary	Change from baseline in Anxiety at 90 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 90
Secondary	Change from baseline in Anxiety at 180 days	Generalized Anxiety Disorder 7-item (GAD-7), a 7-item self-report measure yielding an anxiety severity score between 0 and 21.	day 180
Secondary	Change from baseline in Post-Concussion Symptom Severity at 15 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 15
Secondary	Change from baseline in Post-Concussion Symptom Severity at 90 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 90
Secondary	Change from baseline in Post-Concussion Symptom Severity at 180 days	Neurobehavioral Symptom Inventory (NSI), a 22-item self-report measure yielding a post-concussion symptom severity score between 0 and 88.	day 180
Secondary	Change from baseline in Free testosterone levels at 15 days	Quest diagnostics to measure Free testosterone levels	day 15
Secondary	Change from baseline in Free testosterone levels at 90 days	Quest diagnostics to measure Free testosterone levels	day 90
Secondary	Change from baseline in Free testosterone levels at 180 days	Quest diagnostics to measure Free testosterone levels	day 180
Secondary	Change from baseline in C-reactive protein (CRP) levels at 15 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 15
Secondary	Change from baseline in C-reactive protein (CRP) levels at 90 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 90
Secondary	Change from baseline in C-reactive protein (CRP) levels at 180 days	Quest diagnostics to measure C-reactive protein (CRP) levels	day 180