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The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subanesthetic ketamine infusions and bilateral cervical sympathetic blocks | Procedure | Combined protocol of subanesthetic ketamine infusions and bilateral cervical sympathetic blocks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Epigenetic Aging at 15 days | GrimAge epigenetic clock tool to assess DNA methylation | day 15 |
| Change from baseline in Epigenetic Aging at 90 days | GrimAge epigenetic clock tool to assess DNA methylation | day 90 |
| Change from baseline in Epigenetic Aging at 180 days | GrimAge epigenetic clock tool to assess DNA methylation | day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Lipov, MD | Stella Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stella Center | Recruiting | Westmont | Illinois | 60656 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change from baseline in Free testosterone levels at 15 days | Quest diagnostics to measure Free testosterone levels | day 15 |
| Change from baseline in Free testosterone levels at 90 days | Quest diagnostics to measure Free testosterone levels | day 90 |
| Change from baseline in Free testosterone levels at 180 days | Quest diagnostics to measure Free testosterone levels | day 180 |
| Change from baseline in C-reactive protein (CRP) levels at 15 days | Quest diagnostics to measure C-reactive protein (CRP) levels | day 15 |
| Change from baseline in C-reactive protein (CRP) levels at 90 days | Quest diagnostics to measure C-reactive protein (CRP) levels | day 90 |
| Change from baseline in C-reactive protein (CRP) levels at 180 days | Quest diagnostics to measure C-reactive protein (CRP) levels | day 180 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |