Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial
NCT02393079, Not applicable, Completed, University of Sao Paulo General Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial | ClinicalTrials.gov |
| NCT number | NCT02393079 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 36 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Sao Paulo General Hospital | ClinicalTrials.gov |
| Conditions | Brain Injury, Cognitive Deficits | ClinicalTrials.gov |
| Interventions | Transcranial LED Therapy (TCLT), Sham | ClinicalTrials.gov |
| First posted | 2015-03-19 | ClinicalTrials.gov |
| Last updated | 2022-04-29 | ClinicalTrials.gov |
Registered outcomes 2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evidence of improvement in inhibitory control measured by cognitive assessment (Stroop Test - Victoria Version) in patients undergoing intervention with an active LED helmet. | Three times: Up to one week before to start intervention, one week and three months after end the intervention | Measurement of each patient's inhibitory control by means of a test that causes them to cognitively suppress a habitual response in favor of a less habitual one. The results of patients with shorter response times indicate better positions in the tables, according to age. Examples of the average time (in seconds) of best results are between 17-29 years (11.79) and 80+ (19.31), any time longer than these indicates decreasing results. | ClinicalTrials.gov |
| Secondary | Assess the immediate and late effects of the intervention on victims of moderate or severe TBI in the following cognitive domains: executive functioning, attentional processes and memory. | Three times: Up to one week before to start intervention, one week and three months after end the intervention | Apply a neuropsychological assessment battery focused on executive functioning, attentional processes and memory to measure the effects of the active led helmet compared to the use of the sham device. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 29310710 | DERIVED | PubMed |
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 | 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)