Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans
NCT05671692, Phase 2, Active not recruiting, Christine Marx, MD
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans | ClinicalTrials.gov |
| NCT number | NCT05671692 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 108 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Christine Marx, MD | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury, TBI | ClinicalTrials.gov |
| Interventions | Pregnenolone, Placebo | ClinicalTrials.gov |
| First posted | 2023-01-05 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in psychological health as measured by the Brief Symptom Inventory-18 (BSI) | Baseline, week 8 | The BSI-18 GSI summarizes a respondent's overall level of psychological distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress. The outcome measure is the change in scores before and after treatment (the baseline and Week 8 difference scores). | ClinicalTrials.gov |
| Secondary | Changes in physical health as measured by the 36-Item Short Form Health Survey (SF-36) | Baseline, week 8 | These data report changes in the mean scores in physical health symptoms using the Physical Health Summary sub score of the SF-36. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state. Thus, increases in scores represent improvements relative to baseline. | ClinicalTrials.gov |
| Secondary | Changes in mental health as measured by the 36-Item Short Form Health Survey (SF-36) | Baseline, week 8 | These data report changes in the mean scores in mental health symptoms using the Mental Health Summary sub score of the SF-36. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state. Thus, increases in scores represent improvements relative to baseline. | ClinicalTrials.gov |
| Secondary | Changes in cognition as measured by the Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline, week 8 | WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with functional outcomes. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 90-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed. | ClinicalTrials.gov |
| Secondary | Changes in cognition as measured by the Stroop Color and Word Test (STROOP) | Baseline, week 8 | The Stroop is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The score for the Stroop Test is the number of correct responses provided in 45 seconds on each test condition: word reading, color naming, and inhibition. Scores range from 0 to no upper limit, with higher scores indicating better performance. | ClinicalTrials.gov |
| Secondary | Changes in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5) | Baseline, week 8 | Post-Traumatic Stress Disorder (PTSD) symptoms will be evaluated by the Post-Traumatic Stress Disorder Checklist Scale-Version DSM 5 (PCL-5). This questionnaire contains twenty items to assess PTSD symptoms. A total score for symptom severity (0-80) can be obtained by summing the scores for each of the 20 items. Higher scores are indicative of greater symptomatology. | ClinicalTrials.gov |
| Secondary | Changes in depression symptoms as measured by the Beck Depression Inventory-II (BDI-II) | Baseline, week 8 | The BDI-II is a 21-item, self-report rating inventory that assesses symptoms of depression. Scores range from 0 (no depression) to 63 (severe depression). Higher scores indicate greater depression symptomatology. | ClinicalTrials.gov |
| Secondary | Changes in pain symptoms as measured by the Brief Pain Inventory (BPI) | Baseline, week 8 | The Brief Pain Inventory (BPI) is a self-reported scale that measures the severity of pain symptoms. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The Interference scores range from 0 (does not interfere) to 10 (completely interferes); there are 7 questions assessing the interference of pain. The outcome measure is the change in scores before and after treatment (the baseline and Week 8 difference scores). Higher scores are associated with greater pain. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)