OPTIMA-TBI Pilot Study
NCT03345550, Phase 2, Terminated, University of Michigan; results first posted 2023-05-23
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | OPTIMA-TBI Pilot Study | ClinicalTrials.gov |
| NCT number | NCT03345550 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 44 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Michigan | ClinicalTrials.gov |
| Conditions | Mild Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules., Placebo - Cap | ClinicalTrials.gov |
| First posted | 2017-11-17 | ClinicalTrials.gov |
| Last updated | 2023-05-23 | ClinicalTrials.gov |
| Results first posted | 2023-05-23 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Biomarker Endpoints (NFL) | Baseline,3 months | Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology. | ClinicalTrials.gov |
| Primary | Biomarker Endpoint (Inflammation) | 3 months | We will measure serum levels of high sensitivity C-Reactive Protein (CRP) | ClinicalTrials.gov |
| Primary | Biomarker Endpoint (Neurogenesis) | 3 months | Serum levels of brain derived neurotrophic factor (BDNF) | ClinicalTrials.gov |
| Secondary | Delayed Functional Recovery | 3 months | Delayed functional recovery will be defined as a Glasgow Outcome Scale Extended (GOSE) \<8 at 3 months. Scores range from 1-8. 8 is Upper good recovery and 1 is death | ClinicalTrials.gov |
| Secondary | Gastrointestinal Distress | 3 months | GI distress is measured by number of individuals who experienced it. | ClinicalTrials.gov |
| Secondary | Clinically Significant Bleeding | 3 months | Clinically significant bleeding distress is measured by number of individuals who experienced it. | ClinicalTrials.gov |
| Other | Cognitive Impairment | 3 months | Cognitive impairment will be defined by a battery of neurocognitive tests including the Montreal Cognitive Assessment (MOCA), Hopkins Verbal Learning Test (HVLT), Trails A and B, Brief Visuospatial Memory Test (BVMT), Stroop Test, Wechsler Test of Adult Reading (WTAR), Brief Test of Attention, (BTA), Wisconsin Card Sorting Test (WCST) and COWAT (Controlled Oral Word Association Test). The WTAR will be used as an estimate of IQ and the neurocognitive test T-scores of interest will be compared against the subject's IQ T-score. The standard deviation (SD) of each T-score is 10. Each of the subject's neurocognitive tests is considered aberrant if it is more than 2 SD below the subject's IQ T-score. A subject is considered cognitively impaired if at least 2 (based on the .05 rule; 5 out of every 100 test scores will be outside of expected range by chance alone) out of the T-scores are aberrant. | ClinicalTrials.gov |
| Other | Moderate/Severe Post-Concussive Symptoms | 3 months | Moderate/severe post-concussive symptoms will be defined as the presence of any one or more of the following: headaches, dizziness, general malaise, excessive fatigue, or noise intolerance, irritability, emotional lability, depression, or anxiety, subjective complaints of concentration or memory difficulty, insomnia, reduced tolerance to alcohol, preoccupation with these symptoms and fear of permanent brain damage. These will be self-reported by the patient. | ClinicalTrials.gov |
Outcomes 9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Biomarker Endpoints (NFL) | Baseline,3 months | For some of the assays, some individuals' data was not available. | picograms per ml | MEDIAN | ClinicalTrials.gov |
| PRIMARY | Biomarker Endpoint (Inflammation) | 3 months | While serum was collected no CRP data or measurements were made or can be made now or in the future. | ClinicalTrials.gov | ||
| PRIMARY | Biomarker Endpoint (Neurogenesis) | 3 months | While serum was collected, no BDNF data or measurements were collected or can be made now or in the future. | ClinicalTrials.gov | ||
| SECONDARY | Delayed Functional Recovery | 3 months | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Gastrointestinal Distress | 3 months | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Clinically Significant Bleeding | 3 months | All 22 participants were analyzed on an Intention to Treat analysis. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Cognitive Impairment | 3 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Moderate/Severe Post-Concussive Symptoms | 3 months | ClinicalTrials.gov | |||
| POST_HOC | Glial Fibrillary Acidic Protein (GFAP) | 3 months | Missing blood samples due to loss of follow-up. | picograms per ml | MEAN | ClinicalTrials.gov |
Results by group 20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Biomarker Endpoints (NFL) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | NFL baseline | 7.9 | Inter-Quartile Range 5.1 to 11.4 | picograms per ml | ClinicalTrials.gov |
| Biomarker Endpoints (NFL) | Placebo Arm | NFL baseline | 5.3 | Inter-Quartile Range 4.4 to 10.0 | picograms per ml | ClinicalTrials.gov |
| Biomarker Endpoints (NFL) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | NFL 1 month | 6.7 | Inter-Quartile Range 3.9 to 12.7 | picograms per ml | ClinicalTrials.gov |
| Biomarker Endpoints (NFL) | Placebo Arm | NFL 1 month | 8.7 | Inter-Quartile Range 4.8 to 13.4 | picograms per ml | ClinicalTrials.gov |
| Biomarker Endpoints (NFL) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | NFL 3 months | 8.2 | Inter-Quartile Range 4.1 to 9.5 | picograms per ml | ClinicalTrials.gov |
| Biomarker Endpoints (NFL) | Placebo Arm | NFL 3 months | 9.7 | Inter-Quartile Range 4.6 to 20.0 | picograms per ml | ClinicalTrials.gov |
| Delayed Functional Recovery | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | Upper good recovery at 3 months (GOSE=8) | 16 | Participants | ClinicalTrials.gov | |
| Delayed Functional Recovery | Placebo Arm | Upper good recovery at 3 months (GOSE=8) | 17 | Participants | ClinicalTrials.gov | |
| Delayed Functional Recovery | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | Lower good recovery at 3 months (GOSE=7) | 1 | Participants | ClinicalTrials.gov | |
| Delayed Functional Recovery | Placebo Arm | Lower good recovery at 3 months (GOSE=7) | 0 | Participants | ClinicalTrials.gov | |
| Gastrointestinal Distress | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 3 | Participants | ClinicalTrials.gov | ||
| Gastrointestinal Distress | Placebo Arm | 0 | Participants | ClinicalTrials.gov | ||
| Clinically Significant Bleeding | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 0 | Participants | ClinicalTrials.gov | ||
| Clinically Significant Bleeding | Placebo Arm | 0 | Participants | ClinicalTrials.gov | ||
| Glial Fibrillary Acidic Protein (GFAP) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | Baseline | 77.9 | Inter-Quartile Range 56.8 to 158.0 | picograms per ml | ClinicalTrials.gov |
| Glial Fibrillary Acidic Protein (GFAP) | Placebo Arm | Baseline | 53.7 | Inter-Quartile Range 40.4 to 123.0 | picograms per ml | ClinicalTrials.gov |
| Glial Fibrillary Acidic Protein (GFAP) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 1 month | 51.0 | Inter-Quartile Range 41.3 to 91.0 | picograms per ml | ClinicalTrials.gov |
| Glial Fibrillary Acidic Protein (GFAP) | Placebo Arm | 1 month | 87.7 | Inter-Quartile Range 59.6 to 118.8 | picograms per ml | ClinicalTrials.gov |
| Glial Fibrillary Acidic Protein (GFAP) | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 3 month | 61.2 | Inter-Quartile Range 31.2 to 99.7 | picograms per ml | ClinicalTrials.gov |
| Glial Fibrillary Acidic Protein (GFAP) | Placebo Arm | 3 month | 68.4 | Inter-Quartile Range 45.7 to 129.0 | picograms per ml | ClinicalTrials.gov |
Participant flow 8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 22 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo Arm | 22 | ClinicalTrials.gov | |
| Overall Study | First Received Drug | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 22 | ClinicalTrials.gov | |
| Overall Study | First Received Drug | Placebo Arm | 22 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 17 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo Arm | 17 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 5 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo Arm | 5 | ClinicalTrials.gov |
Adverse events 2
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 |
|---|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 3 | 22 | 3 | ClinicalTrials.gov |
| other | Diarrhea | Gastrointestinal disorders | Placebo Arm | 0 | 22 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 0 | 22 | ClinicalTrials.gov |
| Total, all-cause mortality | Placebo Arm | 0 | 22 | ClinicalTrials.gov |
| Total, other adverse events | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 3 | 22 | ClinicalTrials.gov |
| Total, other adverse events | Placebo Arm | 0 | 22 | ClinicalTrials.gov |
| Total, serious adverse events | Omega-3 Polyunsaturated Fatty Acid Treatment Arm | 0 | 22 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo Arm | 0 | 22 | ClinicalTrials.gov |
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 4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omega-3 Polyunsaturated Fatty Acid Treatment Arm vs Placebo Arm: Gastrointestinal Distress | Trial comparisons |
| Omega-3 Polyunsaturated Fatty Acid Treatment Arm vs Placebo Arm: Clinically Significant Bleeding | Trial comparisons |
| Omega-3 Polyunsaturated Fatty Acid Treatment Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Omega-3 Polyunsaturated Fatty Acid Treatment Arm vs Placebo Arm: serious adverse events | Trial comparisons |
Tests 5
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 |
|---|---|---|
| Card Sorting Test (Berg) | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other 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)