Trial · NCT02019654
An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury
NCT02019654, Completed, National Institute of Nursing Research (NINR)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury. Trials, record NCT02019654. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02019654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury
- NCT number
- NCT02019654
- Status
- Completed
- Enrollment
- 37 participants, actual
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Conditions
- Traumatic Brain Injury, PTSD, Depression
- First posted
- 2013-12-24
- Last updated
- 2022-09-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Examine proteomic concentrations of inflammatory proteins and neuropeptides following TBI and determine if these biomarkers relate to a greater risk for PTSD, depression or PCS. | Visit 1 (Month 1) and Visit 3 (Month 3) | Protein concentrations of inflammatory proteins (IL-1, IL-6, CRP), and lower concentrations of neuropeptides (IGF-1, BDNF, galanin, NPY) and higher concentrations of (SB100, GFAP) collected at the first appointment will predict the onset of PTSD, depression or PCS. |
| Secondary | We will investigate the activation pattern and effective connectivity between the amygdala and other target regions regulating emotions (e.g., vmPFC or ACC) by analyzing fMRI data in patients following a TBI. We propose that the neurocircuitry-b... | Visits: 2, 3 | A model of neurocircuitry of acute stress onset based models of emotion regulation that emphasize the role of the amygdala and its reciprocal interactions with other target regions assessed through the use of a fMRI and the Affective Stroop Task. |
| Secondary | Participants who develop PTSD, depression, or PCS will exhibit differential neuroendocrine functioning test responses using hydrocortisone stimulation test compared to controls who are resistant to these disorders. | Visits: 2,3,4,5 | A comparison of neuroendocrine functioning using the hydrocortisone stimulation between those cases that are compromised and develop PTSD, depression of PCS, and controls without these diagnoses. |
| Secondary | Examine reported sleep quality following the TBI and determine if sleep disturbance is associated with the onset of PTSD, PCS or depression | Visits: 2,3,4,5 | The level of sleep disruption, as well as the reasons for disruption (i.e. sleep onset latency, frequent awakenings) between resistant and compromised participants. The relationship between self-reported health quality and symptomatology related to the development of PTSD, depression and PCS diagnoses. |
| Secondary | Examine epigenetic modifications (i.e. DNA methylation) and genetic predisposition that may relate to the risk of developing PTSD, depression or PCS onset following a TBI. | Visits: 2,3,4,5 | Approximate multiple psychological constructs (i.e. fibromyalgia, chronic fatigue syndrome, etc), the relation between somatization and PTSD/TBI (and potentially the temporal order), and examine levels of overall somatization as a continuous variable across the entire cohort. |
| Secondary | Compare the use of resilience traits/abilities in participants who develop PTSD, depression or PCS to TBI participants who are resistant to these disorders. | Visits: 2,3,4,5 | A profile of resilience abilities and traits that differ between resistant participants and compromised participants. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
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 |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02019654
GET https://conductscience.org/api/trials/v1/NCT02019654/registered