Effects of LEDs on Memory in TBI Patients
NCT01598532, Not applicable, Completed, Spaulding Rehabilitation Hospital; results first posted 2016-08-22
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of LEDs on Memory in TBI Patients | ClinicalTrials.gov |
| NCT number | NCT01598532 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 22 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Spaulding Rehabilitation Hospital | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | MedX Health Phototherapy (light therapy) | ClinicalTrials.gov |
| First posted | 2012-05-15 | ClinicalTrials.gov |
| Last updated | 2016-09-30 | ClinicalTrials.gov |
| Results first posted | 2016-08-22 | ClinicalTrials.gov |
| Limitations and caveats | Small sample size \& Open Protocol | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Stroop Test for Executive Function - Trial 3 - Inhibition | Baseline and 1-Week, 1-month and 2-months after final LED Treatment | Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
| Primary | Stroop Test for Executive Function - Trial 4 Inhibition Switching | Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment | Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
| Primary | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment | California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
| Primary | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
| Primary | Controlled Oral Word Association Test (FAS) | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
| Primary | Digit Span, Forwards and Backwards | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | ClinicalTrials.gov |
Outcomes 6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Stroop Test for Executive Function - Trial 3 - Inhibition | Baseline and 1-Week, 1-month and 2-months after final LED Treatment | All participants enrolled in the Transcranial LED Treatment Group | # of SD units | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Test for Executive Function - Trial 4 Inhibition Switching | Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment | All participants enrolled in Transcranial LED Treatment Group | # of SD Units | MEAN | ClinicalTrials.gov |
| PRIMARY | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment | All participants enrolled in Real Intervention Group | # of SD Units | MEAN | ClinicalTrials.gov |
| PRIMARY | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | All participants enrolled in Transcranial LED Treatment Group | # of SD Units | MEAN | ClinicalTrials.gov |
| PRIMARY | Controlled Oral Word Association Test (FAS) | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | All participants enrolled in the Transcranial LED Treatment Group | # of SD units | MEAN | ClinicalTrials.gov |
| PRIMARY | Digit Span, Forwards and Backwards | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | All participants enrolled in the Transcranial LED Treatment Group | # of SD units | MEAN | ClinicalTrials.gov |
Results by group 24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Stroop Test for Executive Function - Trial 3 - Inhibition | Transcranial LED Treatment | Pre-test data | -0.7407 | Standard Deviation 1.1561 | # of SD units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 3 - Inhibition | Transcranial LED Treatment | 1 Week post test data | .036 | Standard Deviation .7407 | # of SD units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 3 - Inhibition | Transcranial LED Treatment | 1 Month post test data | .718 | Standard Deviation 1.0133 | # of SD units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 3 - Inhibition | Transcranial LED Treatment | 2 Months post test data | .815 | Standard Deviation .9499 | # of SD units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | Transcranial LED Treatment | Pre-test data | -1.050 | Standard Deviation 1.1058 | # of SD Units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | Transcranial LED Treatment | 1 week post test data | -0.100 | Standard Deviation 1.3994 | # of SD Units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | Transcranial LED Treatment | 1 Month post test data | .553 | Standard Deviation 1.167 | # of SD Units | ClinicalTrials.gov |
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | Transcranial LED Treatment | 2 Month post test data | .854 | Standard Deviation 1.3544 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Transcranial LED Treatment | Pre-test Data | -.409 | Standard Deviation .7687 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Transcranial LED Treatment | 1 Week post test data | .364 | Standard Deviation .809 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Transcranial LED Treatment | 1 Month post test data | .630 | Standard Deviation .7015 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Transcranial LED Treatment | 2 Month post test data | .780 | Standard Deviation .9724 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Transcranial LED Treatment | Pre-test data | -1.136 | Standard Deviation 1.4334 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Transcranial LED Treatment | 1 Week post test data | -0.136 | Standard Deviation 1.1851 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Transcranial LED Treatment | 1 Month post test data | -0.200 | Standard Deviation 1.249 | # of SD Units | ClinicalTrials.gov |
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Transcranial LED Treatment | 2 Month post test data | 0.050 | Standard Deviation 1.15 | # of SD Units | ClinicalTrials.gov |
| Controlled Oral Word Association Test (FAS) | Transcranial LED Treatment | Pre-test data | -.318 | Standard Deviation 1.54 | # of SD units | ClinicalTrials.gov |
| Controlled Oral Word Association Test (FAS) | Transcranial LED Treatment | 1 Week post test data | .136 | Standard Deviation 1.45 | # of SD units | ClinicalTrials.gov |
| Controlled Oral Word Association Test (FAS) | Transcranial LED Treatment | 1 Month post test data | .114 | Standard Deviation 1.58 | # of SD units | ClinicalTrials.gov |
| Controlled Oral Word Association Test (FAS) | Transcranial LED Treatment | 2 Month post test data | .285 | Standard Deviation 1.38 | # of SD units | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Transcranial LED Treatment | 22 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Transcranial LED Treatment | 11 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Transcranial LED Treatment | 11 | ClinicalTrials.gov |
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 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Transcranial LED Treatment | ClinicalTrials.gov | ||
| Total, other adverse events | Transcranial LED Treatment | 0 | 11 | ClinicalTrials.gov |
| Total, serious adverse events | Transcranial LED Treatment | 0 | 11 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | 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)