Traumatic Brain Injury
Conditions
Keywords
mild traumatic brain injury, mild TBI, mTBI
Brief summary
The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.
Detailed description
This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury. Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.
Interventions
DEVICEMedX Health Phototherapy (light therapy)
The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, Ages 18-65 * sustained a mild traumatic brain injury(mTBI) at least 6 months ago * mTBI is defined as \< 30 minutes loss of consciousness and \<30 minutes, post trauma amnesia * since the injury patient continues having problems with memory and thinking ability
Exclusion criteria
* Younger than 18 or older than 65 * mTBI occured less than 6 months ago * moderate to severe Traumatic Brain Injury (TBI) * non-closed head injury * presence of craniotomy, craniectomy, or ventriculoperitoneal shunt * Non-English speaking subjects - Neuropsychological Tests only in English * Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for the study began in April 2010. Potential subjects were recruited through several different methods - Spaulding Rehabilitation Hospital outpatient clinic, advertisements in local area newspapers, Brain Injury Association of MA and other area organizations that provide services to TBI survivors, flyers, on-line and social media.
Pre-assignment details
22 study subjects signed the consent but only 11 completed the study. The 11 that did not completed the study either did not meet the inclusion criteria at Screening or were lost to follow-up after they screened for the study.
Participants by arm
| Arm | Count |
|---|---|
| Transcranial LED Treatment All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.
The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.
The following tests were not analyzed due to collinearity with other measures (r \> .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria | 8 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Transcranial LED Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
| Time Post TBI | 3.12 years post TBI STANDARD_DEVIATION 2.5 |
| Years of Education | 15.72 Years of Education STANDARD_DEVIATION 2.97 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall
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.
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Population: All participants enrolled in Transcranial LED Treatment Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | Pre-test data | -1.136 # of SD Units | Standard Deviation 1.4334 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | 1 Week post test data | -0.136 # of SD Units | Standard Deviation 1.1851 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | 1 Month post test data | -0.200 # of SD Units | Standard Deviation 1.249 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | 2 Month post test data | 0.050 # of SD Units | Standard Deviation 1.15 |
Comparison: linear trend over time for the effects of LED treatmentsp-value: <0.006ANOVA
Primary
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5
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.
Time frame: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
Population: All participants enrolled in Real Intervention Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | Pre-test Data | -.409 # of SD Units | Standard Deviation 0.7687 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | 1 Week post test data | .364 # of SD Units | Standard Deviation 0.809 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | 1 Month post test data | .630 # of SD Units | Standard Deviation 0.7015 |
| Transcranial LED Treatment | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | 2 Month post test data | .780 # of SD Units | Standard Deviation 0.9724 |
Comparison: linear trend over time for effect of LED treatmentsp-value: <0.003ANOVA
Primary
Controlled Oral Word Association Test (FAS)
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.
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Population: All participants enrolled in the Transcranial LED Treatment Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | Controlled Oral Word Association Test (FAS) | Pre-test data | -.318 # of SD units | Standard Deviation 1.54 |
| Transcranial LED Treatment | Controlled Oral Word Association Test (FAS) | 1 Week post test data | .136 # of SD units | Standard Deviation 1.45 |
| Transcranial LED Treatment | Controlled Oral Word Association Test (FAS) | 1 Month post test data | .114 # of SD units | Standard Deviation 1.58 |
| Transcranial LED Treatment | Controlled Oral Word Association Test (FAS) | 2 Month post test data | .285 # of SD units | Standard Deviation 1.38 |
Primary
Digit Span, Forwards and Backwards
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.
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Population: All participants enrolled in the Transcranial LED Treatment Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | Digit Span, Forwards and Backwards | Pre-test data | -.182 # of SD units | Standard Deviation 1.45 |
| Transcranial LED Treatment | Digit Span, Forwards and Backwards | 1 Week post test data | .318 # of SD units | Standard Deviation 1.31 |
| Transcranial LED Treatment | Digit Span, Forwards and Backwards | 1 Month post test data | .444 # of SD units | Standard Deviation 1.42 |
| Transcranial LED Treatment | Digit Span, Forwards and Backwards | 2 Month post test data | .650 # of SD units | Standard Deviation 1.52 |
Primary
Stroop Test for Executive Function - Trial 3 - Inhibition
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.
Time frame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment
Population: All participants enrolled in the Transcranial LED Treatment Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 3 - Inhibition | Pre-test data | -0.7407 # of SD units | Standard Deviation 1.1561 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 3 - Inhibition | 1 Week post test data | .036 # of SD units | Standard Deviation 0.7407 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 3 - Inhibition | 1 Month post test data | .718 # of SD units | Standard Deviation 1.0133 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 3 - Inhibition | 2 Months post test data | .815 # of SD units | Standard Deviation 0.9499 |
Comparison: linear trend over time for the effect of LED treatmentsp-value: <0.004ANOVA
Primary
Stroop Test for Executive Function - Trial 4 Inhibition Switching
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.
Time frame: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
Population: All participants enrolled in Transcranial LED Treatment Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 4 Inhibition Switching | Pre-test data | -1.050 # of SD Units | Standard Deviation 1.1058 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 4 Inhibition Switching | 1 week post test data | -0.100 # of SD Units | Standard Deviation 1.3994 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 4 Inhibition Switching | 1 Month post test data | .553 # of SD Units | Standard Deviation 1.167 |
| Transcranial LED Treatment | Stroop Test for Executive Function - Trial 4 Inhibition Switching | 2 Month post test data | .854 # of SD Units | Standard Deviation 1.3544 |
Comparison: linear trend over time for the effect of LED treatmentsp-value: <0.003ANOVA