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LED Therapy for the Treatment of Concussive Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02383472
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : June 29, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
United States Department of Defense
National Football League
Information provided by (Responsible Party):
William Meehan III, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Brain Concussion
Interventions Device: MedX Health Console model 1100
Device: MedX Health Console model 1100-placebo
Enrollment 53
Recruitment Details Recruitment began in the September of 2012 from the Concussion Clinic within the Department of Sports Medicine and lasted through the spring on 2016.
Pre-assignment Details  
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.

Period Title: Overall Study
Started 23 30
Completed 22 29
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo Total
Hide Arm/Group Description

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.

Total of all reporting groups
Overall Number of Baseline Participants 22 29 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 29 participants 51 participants
21.55  (13.12) 21.21  (13.25) 21.35  (13.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
Female
13
  59.1%
19
  65.5%
32
  62.7%
Male
9
  40.9%
10
  34.5%
19
  37.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   6.9%
2
   3.9%
White
22
 100.0%
27
  93.1%
49
  96.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Participants taking stimulant medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
10
  45.5%
14
  48.3%
24
  47.1%
Migraine Headache  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
2
   9.1%
7
  24.1%
9
  17.6%
Psychiatric hx  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
Undefined
14
  63.6%
22
  75.9%
36
  70.6%
Anxiety
1
   4.5%
0
   0.0%
1
   2.0%
Depression
0
   0.0%
3
  10.3%
3
   5.9%
PTSD
1
   4.5%
0
   0.0%
1
   2.0%
Neurodevelopmental Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
ADHD
5
  22.7%
2
   6.9%
7
  13.7%
Learning Disability
1
   4.5%
2
   6.9%
3
   5.9%
Prior Concussions  
Mean (Full Range)
Unit of measure:  Concussions
Number Analyzed 22 participants 29 participants 51 participants
3.5
(1 to 10)
2
(1 to 6)
2.5
(1 to 10)
Injury characteristics  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
Sport-related concussion
14
  63.6%
22
  75.9%
36
  70.6%
Loss of Consciousness
3
  13.6%
3
  10.3%
6
  11.8%
Amnesia
8
  36.4%
10
  34.5%
18
  35.3%
1.Primary Outcome
Title Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.
Hide Description The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.
Time Frame From baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description:

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Verbal Memory -0.9  (17.11) -5.78  (12.08)
Visual Memory 3.52  (14.82) -7.26  (12.07)
Visual Motor Speed -2.04  (6.36) -5.15  (5.04)
Reaction Time -0.001  (0.16) 0.030  (0.18)
Symptom Score 10.14  (10.13) 11.44  (19.07)
2.Secondary Outcome
Title Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.
Hide Description This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.
Time Frame From baseline to 3 weeks and from baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description:

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: Seconds
D-KEFs Color Naming - 3 Weeks 3.27  (4.03) 4.76  (8.88)
D-KEFs Color Naming - 6 Weeks 3.76  (5.12) 4.07  (9.00)
D-KEFs Word Reading - 3 Weeks 0.95  (2.98) 4.07  (10.05)
D-KEFs Word Reading - 6 Weeks 1.71  (3.73) 3.44  (13.98)
D-KEFs Inhibition - 3 Weeks 7.64  (5.49) 4.48  (17.00)
D-KEFs Inhibition - 6 Weeks 32.62  (9.13) 31.59  (14.73)
D-KEFs Number Sequencing - 3 weeks -24.45  (15.04) -21.17  (17.55)
D-KEFs Letter Sequencing- 3 weeks -28.41  (14.06) -19.51  (20.15)
D-KEFs Number-Letter Sequencing- 3 weeks 8.00  (12.66) 21.93  (32.19)
D-KEFs Number Sequencing - 6 weeks 11.33  (7.3) 6.89  (10.78)
D-KEFs Letter Sequencing- 6 weeks 6.86  (4.29) 10.59  (9.49)
D-KEFs Number-Letter Sequencing- 6 weeks 12.95  (13.28) 19.81  (30.34)
3.Secondary Outcome
Title Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.
Hide Description This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs Verbal Fluency Test, made up of letter fluency and category fluency, is measured by number of responses, a larger number represents a better outcome. Participants were given 60 seconds to complete each fluency test.
Time Frame From baseline to 3 weeks and from baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description:

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: Correct responses
D-KEFs Verbal Fluency- letters 3 weeks -3.45  (6.52) -6.10  (8.26)
D-KEFs Verbal Fluency- letters 6 weeks -6.71  (7.89) -9.89  (11.34)
D-KEFs Verbal Fluency- category 3 weeks -1.14  (4.17) -0.03  (4.12)
D-KEFs Verbal Fluency- category 6 weeks -1.62  (4.09) -2.00  (4.62)
4.Secondary Outcome
Title Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.
Hide Description This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.
Time Frame From baseline to 3 weeks and from baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description:

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
PCSS Total Score - 3 Weeks 9.41  (12.62) 7.03  (16.96)
PCSS Total score - 6 Weeks 7.86  (14.5) 14.63  (23.41)
5.Secondary Outcome
Title Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6
Hide Description This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like "in a fog", "don't feel right", difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome.
Time Frame From baseline to 3 weeks and from baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description:

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cognitive Sx Score - 3 Weeks 3.95  (6.56) 1.31  (6.96)
Cognitive Sx Score - 6 Weeks 4.00  (6.59) 5.00  (8.95)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Hide Arm/Group Description

The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 “for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches.” Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar

Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.

MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r

All-Cause Mortality
MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MedX Health Console Model 1100 MedX Health Console Model 1100-placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/23 (4.35%)      0/30 (0.00%)    
Skin and subcutaneous tissue disorders     
Discomfort * [1]  1/23 (4.35%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient complained cluster heads were "uncomfortable and hot"
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. William Meehan
Organization: Boston Children's Hospital
Phone: 781-216-1328
Publications:
Responsible Party: William Meehan III, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02383472     History of Changes
Other Study ID Numbers: IRB-P00002527
First Submitted: March 4, 2015
First Posted: March 9, 2015
Results First Submitted: March 21, 2018
Results First Posted: June 29, 2018
Last Update Posted: July 25, 2018