Trial Outcomes & Findings for Light Therapy for Moderate Traumatic Brain Injury (NCT NCT02233413)
NCT ID: NCT02233413
Last Updated: 2020-12-03
Results Overview
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
up to seven days after enrollment
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Non-active LLLT Helmet Application
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
| Measure |
Non-active LLLT Helmet Application
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
Light Therapy for Moderate Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Non-active LLLT Helmet Application
n=24 Participants
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=19 Participants
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.00 years
STANDARD_DEVIATION 14.68 • n=5 Participants
|
46.05 years
STANDARD_DEVIATION 19.93 • n=7 Participants
|
50.49 years
STANDARD_DEVIATION 17.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Injury Mechanism
Bike/Motorcycle Accident with Helmet
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Injury Mechanism
Bike/Motorcycle Accident without Helmet
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Injury Mechanism
Fall
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Injury Mechanism
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Injury Mechanism
Pedestrian accident with car/motorcycle/bike
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Injury Mechanism
Restrained Automobile Accident
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Injury Mechanism
Unrestrained Automobile Accident
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Injury Mechanism
Violence/assault
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to seven days after enrollmentPopulation: Subjects who completed light or sham treatment and at least one MRI scan. 43 patients completed the study with at least one MRI scan, 19 subjects in the Light treatment group and 24 subjects in the sham treatment group.
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
Outcome measures
| Measure |
Non-active LLLT Helmet Application
n=24 Participants
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=19 Participants
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Safety and Feasibility of Applying Light Therapy After Moderate TBI
|
24 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 3 months after treatmentPopulation: Of the 68 patients that were randomized, 28 completed at least one light therapy session. 43 patients completed the study with at least one MRI scan. 19 subjects in the light treatment group and 24 subjects in the sham treatment group. One MRI was deemed low quality and excluded from analysis (19 light treatment / 23 sham)
The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions. periventricular white matter (PVWM). 0 = absent 1. = "caps" or pencil-thin lining 2. = smooth "halo" 3. = irregular periventricular signal extending into the deep white matter A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.
Outcome measures
| Measure |
Non-active LLLT Helmet Application
n=23 Participants
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=19 Participants
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
PVWM: Absent / "Caps" or pencil-thin lining (1)
|
19 Participants
|
18 Participants
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
PVWM: Smooth "halo" (2)
|
3 Participants
|
1 Participants
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
PVWM: Irregular periventricular signal (3)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 months after treatmentThe presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions. deep white matter (DWM) 0 = absent 1. = punctate foci 2. = beginning confluence 3. = large confluent areas A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.
Outcome measures
| Measure |
Non-active LLLT Helmet Application
n=23 Participants
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=19 Participants
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
DWM: Absent(0)/Puctuate foci(1)
|
19 Participants
|
16 Participants
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
DWM: Beginning confluence (2)
|
3 Participants
|
3 Participants
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
DWM: Large confluent areas
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are
Outcome measures
| Measure |
Non-active LLLT Helmet Application
n=24 Participants
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=18 Participants
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
RPQ-3
|
4.55 score on a scale
Standard Deviation 3.13
|
3.94 score on a scale
Standard Deviation 3.19
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
RPQ-13
|
12.64 score on a scale
Standard Deviation 7.83
|
10.94 score on a scale
Standard Deviation 9.98
|
|
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
RPQ-Total
|
17.18 score on a scale
Standard Deviation 10.01
|
14.88 score on a scale
Standard Deviation 12.08
|
Adverse Events
Non-active LLLT Helmet Application
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Active LLLT Helmet Application
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-active LLLT Helmet Application
n=31 participants at risk
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=28 participants at risk
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Surgical and medical procedures
Operation for tibial & fibular fracture
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Nervous system disorders
Subdural hematoma
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Infections and infestations
MSSA bacteremia
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Nervous system disorders
Hospital visit due to headache
|
9.7%
3/31 • Number of events 3 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Rectal foreign body
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
Other adverse events
| Measure |
Non-active LLLT Helmet Application
n=31 participants at risk
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Non-active LLLT helmet application: LED helmet applied without light activated
|
Active LLLT Helmet Application
n=28 participants at risk
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Active LLLT helmet application: LED helmet applied with light activated
|
|---|---|---|
|
Nervous system disorders
Symptom reporting
|
41.9%
13/31 • Number of events 13 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
35.7%
10/28 • Number of events 10 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Persistent cough
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Nervous system disorders
Numbness/tingling in toes
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Glass from motor vehicle accident removed
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Broken nose
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Fracture repair
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Social circumstances
Alcohol abuse
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 6 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal neck pain
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Social circumstances
Fall
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Dislocated shoulder
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Eye disorders
Cataract surgery
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 2 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
0.00%
0/28 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Shoulder sprain
|
3.2%
1/31 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
|
Reproductive system and breast disorders
Hemorrhagic cyst
|
0.00%
0/31 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place