tPBM in Older Adults With Traumatic Brain Injury
NCT06956404, Not applicable, Recruiting, NYU Langone Health
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | tPBM in Older Adults With Traumatic Brain Injury | ClinicalTrials.gov |
| NCT number | NCT06956404 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | NYU Langone Health | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | Transcranial photobiomodulator (tPBM), Transcranial photobiomodulator (tPBM) in sham mode | ClinicalTrials.gov |
| First posted | 2025-05-04 | ClinicalTrials.gov |
| Last updated | 2026-01-15 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in prefrontal Cerebral Blood Flow (CBF) | Baseline, end-of-treatment (up to 6 weeks) | CBF will be demonstrated by using arterial spin-labeled (ASL) magnetic resonance imaging (MRI), a method that can reliably quantify absolute CBF level across longer time intervals | ClinicalTrials.gov |
| Primary | Change in Executive Function (EF) composite scores | Baseline, end-of-treatment (up to 6 weeks) | EF composite scores will be derived from five neuropsychological tests (Repeatable Battery for the Assessment of Neuropsychological Status - RBANS, Stroop Color-Word Test, Controlled Oral Word Association Test/FAS, Trail Making Test-A\& B) that assess various aspects of EF. | ClinicalTrials.gov |
| Secondary | Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) | Baseline, end-of-treatment (up to 6 weeks) | The SAFTEE-SI is a commonly used instrument originally developed by National Institute of Mental Health (NIMH) and adapted into a self-report instrument. The scale examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. | 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 4
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 | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary 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)