Post-Traumatic Stress DisorderNCT05855876
Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
An observational study of Post-Traumatic Stress Disorder and Traumatic Brain Injury, run by Stella Center at 1 site in United States.
Trial summary
The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- subanesthetic ketamine infusions and bilateral cervical sympathetic blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will include 20 individuals, 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.
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stella Center
Westmont, Illinois, 60656
Eugene Lipov, MD, 773-992-1349, hope4ptsi@gmail.com
About this study
The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.
Read the detailed 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.
- Being tested
- subanesthetic ketamine infusions and bilateral cervical sympathetic blocks
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subanesthetic ketamine infusions and bilateral cervical sympathetic blocksProcedure or surgery
Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Epigenetic Aging at 15 days
GrimAge epigenetic clock tool to assess DNA methylation
Measured: day 15
Change from baseline in Epigenetic Aging at 90 days
GrimAge epigenetic clock tool to assess DNA methylation
Measured: day 90
Change from baseline in Epigenetic Aging at 180 days
GrimAge epigenetic clock tool to assess DNA methylation
Measured: day 180
Secondary outcomes (21)
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.
Measured: day 15
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.
Measured: day 90
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.
Measured: day 180
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.
Measured: day 15
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.
Measured: day 90
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.
Measured: day 180
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.
Measured: day 15
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.
Measured: day 90
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.
Measured: day 180
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.
Measured: day 15
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.
Measured: day 90
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.
Measured: day 180
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.
Measured: day 15
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.
Measured: day 90
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.
Measured: day 180
Change from baseline in Free testosterone levels at 15 days
Quest diagnostics to measure Free testosterone levels
Measured: day 15
Change from baseline in Free testosterone levels at 90 days
Quest diagnostics to measure Free testosterone levels
Measured: day 90
Change from baseline in Free testosterone levels at 180 days
Quest diagnostics to measure Free testosterone levels
Measured: day 180
Change from baseline in C-reactive protein (CRP) levels at 15 days
Quest diagnostics to measure C-reactive protein (CRP) levels
Measured: day 15
Change from baseline in C-reactive protein (CRP) levels at 90 days
Quest diagnostics to measure C-reactive protein (CRP) levels
Measured: day 90
Change from baseline in C-reactive protein (CRP) levels at 180 days
Quest diagnostics to measure C-reactive protein (CRP) levels
Measured: day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start5 Jul 2023
- Primary completion5 Apr 2024 (estimated)
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stella Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Lipov, Stella Center
- Investigators
- Eugene Lipov, MD, Principal investigator, Stella Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855876
- Sponsor's protocol ID
- ROBRA
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
- ClinicalTrials.gov ID
- NCT05855876
- Acronym / sponsor ID
- ROBRA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stella CenterUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 5 Apr 2024 (estimated)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include 20 individuals, 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subanesthetic ketamine infusions and bilateral cervical sympathetic blocksCombined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks | Procedure or surgery | – |
Primary outcome
Change from baseline in Epigenetic Aging at 15 days
Time frame: day 15
GrimAge epigenetic clock tool to assess DNA methylation
Change from baseline in Epigenetic Aging at 90 days
Time frame: day 90
GrimAge epigenetic clock tool to assess DNA methylation
Change from baseline in Epigenetic Aging at 180 days
Time frame: day 180
GrimAge epigenetic clock tool to assess DNA methylation
21 secondary outcomes
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 15 days
Time frame: day 15
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days
Time frame: day 90
Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 180 days
Time frame: day 180
Change from baseline in Depression at 15 days
Time frame: day 15
Change from baseline in Depression at 90 days
Time frame: day 90
Change from baseline in Depression at 180 days
Time frame: day 180
Change from baseline in Suicidal Ideation at 15 days
Time frame: day 15
Change from baseline in Suicidal Ideation at 90 days
Time frame: day 90
Change from baseline in Suicidal Ideation at 180 days
Time frame: day 180
Change from baseline in Anxiety at 15 days
Time frame: day 15
Change from baseline in Anxiety at 90 days
Time frame: day 90
Change from baseline in Anxiety at 180 days
Time frame: day 180
Change from baseline in Post-Concussion Symptom Severity at 15 days
Time frame: day 15
Change from baseline in Post-Concussion Symptom Severity at 90 days
Time frame: day 90
Change from baseline in Post-Concussion Symptom Severity at 180 days
Time frame: day 180
Change from baseline in Free testosterone levels at 15 days
Time frame: day 15
Change from baseline in Free testosterone levels at 90 days
Time frame: day 90
Change from baseline in Free testosterone levels at 180 days
Time frame: day 180
Change from baseline in C-reactive protein (CRP) levels at 15 days
Time frame: day 15
Change from baseline in C-reactive protein (CRP) levels at 90 days
Time frame: day 90
Change from baseline in C-reactive protein (CRP) levels at 180 days
Time frame: day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Lipov, MD principal investigator
Stella Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder and Traumatic Brain Injury, run by Stella Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Epigenetic Aging at 15 days (time frame: day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.