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Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness

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: NCT01782378
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental treatment uses light-emitting diodes (LEDs), that are applied outside the skull, to the head using a helmet that is lined with near-infrared diodes. LEDs are also placed in the nostrils (one red diode; and one near-infrared diode), near-infrared photons to the olfactory bulbs located on the orbito-frontal cortex. There are connections between the olfactory bulbs and the hippocampus. A treatment takes about 30 minutes. The participants receive a series of LED treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The FDA considers the helmet LED device used here, to be a non-significant risk device. The diodes in the device placed in the nose are low-risk devices, within the FDA Category of General Wellness. In addition, a single, 90 mW near-infrared (NIR) LED was placed on each ear. The LEDs do not produce heat.

Condition or disease Intervention/treatment Phase
Gulf War Veterans Illness Neurobehavioral Manifestations Memory Disorders Device: Real LED Treatment Device: Sham LED Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This was a blinded, randomized, sham-controlled partial crossover study, with 2 Groups. Group 1: Sham LED Series First followed by optional Real LED Series Second. Group 2: One Real LED Series, only. Neuropsychological (NP) tests were completed at Entry (T1), within 1 week post- (T2) and at 1 month post- the 15th treatment (T3) (First series). NP testing was administered after the optional Second Real Series within 1 week post- (T4) and at 1 month post- the 15th treatment (T5). Primary Outcome Measures included NP tests in 3 domains: 1) Attention/Executive Function; 2) Learning and Memory; 3) Psychomotor/Visual Spatial. The Secondary Outcome Measures included sleep, pain, fatigue, and mood.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The participant and the person administering treatments wore goggles (LS-DIO, Phillips Safety Products, Inc.) that blocked 600-900nm wavelengths including red 633 nm wavelength, emitted from the red Intranasal diode. All participants were randomly assigned by computer to Group 1 (Sham First) or Group 2 (Real First) in blocks of 10.
Primary Purpose: Treatment
Official Title: Transcranial, Light-Emitting Diode (LED) Therapy to Improve Cognition in GWVI
Actual Study Start Date : January 9, 2015
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : August 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Real LED Treatment Series
Participants in this group receive a series of 15 real LED treatments with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (633 nm, and 810 nm, Vielight, Inc., Toronto), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads (MedX Health, Toronto) were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and the person performing the treatment wore goggles that block red wavelength (from the red intranasal). Real or Sham LED devices look and feel identical.
Device: Real LED Treatment

PhotoMedex Helmet: 12 Pods, 4.5 x 4.8cm (21.6 cm2); 20 diodes; 830nm; Power Output (PO) 665.3 mW; Power Density (PD)/LED 30.8 mW/cm2; CW; Time/session 28m 10s*; Dose: Energy Density 26 J/cm2.

MedX Device: 1 Cluster Head/ear, 2 inch diameter (22.48 cm2); 870nm; PO 90 mW; PD/LED 4 mW/cm2; CW; Time/session 4m; Energy Density 4 J/cm2; 2 Vielight Intranasal Devices: Red, 633nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; CW; Time/session 25m; Energy Density 11.4 J/cm2 and NIR, 810nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; Pulse frequency 10Hz; Duty Cycle 50%; Time/session 25m; Energy Density 11.4 J/cm2 Thor Photomedicine Helmet: 10 Pods, 6cm diameter (28.3 cm2); 35 diodes; Wavelength 850nm; PO 1050 mW; PD/LED 50 mW/cm2; CW; Time/session 23m, 24s; Energy Density 26 J/cm2 2 Placement sets: 1) midline, 6 cluster heads; 2) L&R side of head 12 cluster heads (14m, 5s, each set); 1) midline, 5 cluster heads; 2) L&R side of head 10 cluster heads (11m, 42s, each set) CW, Continuous Wave

Other Name: Photomedex Helmet, Thor Photomedicine Helmet, MedX LED cluster heads, Vielight Intranasal

Sham Comparator: Sham LED Treatment Series
Participants in this group first receive a series of 15 sham LED treatments with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial LED Helmet and two intranasal nose clips (sham LEDs, Vielight, Inc., Toronto), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two sham LED cluster heads (MedX Health, Toronto) were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and the person performing the treatment wore goggles that block red wavelength (from the red intranasal). Real or Sham LED devices look and feel identical.
Device: Real LED Treatment

PhotoMedex Helmet: 12 Pods, 4.5 x 4.8cm (21.6 cm2); 20 diodes; 830nm; Power Output (PO) 665.3 mW; Power Density (PD)/LED 30.8 mW/cm2; CW; Time/session 28m 10s*; Dose: Energy Density 26 J/cm2.

MedX Device: 1 Cluster Head/ear, 2 inch diameter (22.48 cm2); 870nm; PO 90 mW; PD/LED 4 mW/cm2; CW; Time/session 4m; Energy Density 4 J/cm2; 2 Vielight Intranasal Devices: Red, 633nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; CW; Time/session 25m; Energy Density 11.4 J/cm2 and NIR, 810nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; Pulse frequency 10Hz; Duty Cycle 50%; Time/session 25m; Energy Density 11.4 J/cm2 Thor Photomedicine Helmet: 10 Pods, 6cm diameter (28.3 cm2); 35 diodes; Wavelength 850nm; PO 1050 mW; PD/LED 50 mW/cm2; CW; Time/session 23m, 24s; Energy Density 26 J/cm2 2 Placement sets: 1) midline, 6 cluster heads; 2) L&R side of head 12 cluster heads (14m, 5s, each set); 1) midline, 5 cluster heads; 2) L&R side of head 10 cluster heads (11m, 42s, each set) CW, Continuous Wave

Other Name: Photomedex Helmet, Thor Photomedicine Helmet, MedX LED cluster heads, Vielight Intranasal

Device: Sham LED Treatment
Intervention for Real and Sham are Identical, but sham has power output of 0, no photons emitted.




Primary Outcome Measures :
  1. Digit Span Forwards [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Repeat a series of numbers, exactly as spoken, in the same order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, testing is discontinued. Scoring: 2 points both trials per set; 1 point 1 trial; 0 points failed both trials Forwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome

  2. Digit Span Backwards [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Repeat a series of numbers, in reverse order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, the test is discontinued. Scoring: 2 points both trials correct for each set; 1point 1 trial correct; 0 points no trials Backwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome

  3. Digit Span Total Forward + Backwards [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Total (Forwards+Backwards); measures Attention/Executive Function; working memory with a min score of 0 and a max score of 28; higher score = better outcome

  4. Trails Condition 2 [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Delis-Kaplan Executive Function (DKEFS) Trails 2; Number Sequencing; measures Attention/Executive Function Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

  5. Trails Condition 4 [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Delis-Kaplan Executive Function (DEKFS) Trails 4; Number-Letter Switching; measures Attention/Executive Function Reaction Time lower is better Connect numbers and letters, alternating between numbers and letters. (1-A-2-B...) as quickly as possible. Ends at P.

  6. Stroop Inhibition (Trial 3) [ Time Frame: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series ]
    Color-Word Interference Test Trial 3; measures Attention/Executive Function; inhibition Reaction Time lower = better outcome Name the color ink each word is printed in for a series of words, as quickly as possible.

  7. Stroop Inhibition/Switching [ Time Frame: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series ]
    Color-Word Interference Test Trial 4 (Inhibition/Switching); measures Attention/Executive Function Reaction Time lower = better outcome Participants must sometimes name the color ink in which the word (color) is printed or, if there is a box around the word, they must read the word.

  8. California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    CVLT-II Total Trials 1-5, measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list A read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

  9. CVLT-II, Short Delay Free Recall [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    California Verbal Learning Test -II, Short Delay Free Recall, measures Memory; with min score of 0 and a max score of 16; higher score = better outcome A second list B is presented for one trial of recall before asking participants to recall items from the first list A. Number of items recalled from list A is scored.

  10. CVLT-II, Short Delay Cued Recall [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    California Verbal Learning Test -II, Short Delay Cued Recall, measures Learning/Memory; with a min score of 0 and a max score of 16; higher score = better outcome Participants are now asked to recall items from list A again, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  11. CVLT-II Long Delay Free Recall [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    California Verbal Learning Test- II, Long Delay (20 min) Free Recall, measures Memory with a min score of 0 and a max score of 16; higher score = better outcome After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

  12. CVLT-II Long Delay Cued Recall [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    California Verbal Learning Test- II, Long Delay (20 min) Cued Recall measures Memory; with a min score of 0 and a max score of 16; higher score = better outcome After 20 minute delay participant is given cues (4 categories) and asked to recall the words within each category. Total number of items recalled across all categories.

  13. Conner's Continuous Performance Test II (CPT) False Alarms [ Time Frame: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    CPT; False Alarms (Administered on laptop computer) measures Selective and Sustained Attention percent errors; lower = better outcome Participant presses space bar when an X appears on screen. False alarms is number of errors made (responding to non-targets), reported as percentage.

  14. CPT Correct Detections, Reaction Time (RT) [ Time Frame: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Conner's Continuous Performance Test II; Mean Correct Detections, Reaction Time, (Administered on laptop computer) measures Selective and Sustained Attention; shorter = better outcome Participant must press the space bar when they see an X. Reaction Time for correct responses only.

  15. Conner's Continuous Performance Test II (CPT), D' [ Time Frame: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Conner's Continuous Performance Test II (CPT); D' (sensitivity index) (Administered on laptop computer) measures Selective and Sustained Attention; ability to detect the signal (x) within noise; values range -2 to 2; higher value better Value d' is a measure of the difference between the signal (X) and noise (non-target letters) distributions, assessing the participant's discriminative power.

  16. Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]

    ROCFT; Immediate Recall measures Visuospatial memory with min 0 and max 36; higher score better outcome Participant is presented with a figure. They are asked to copy the figure. Then they are immediately asked to recall and draw the figure.

    Figure is scored on 18 units; up to 2 points per unit Scoring based on accuracy and placement of figure parts: A score of 0, 0.5 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.


  17. ROCFT, Delayed Recall [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]

    Rey Osterrieth Complex Figure Test (ROCFT); Delayed (20-min) Recall measures Visuospatial memory with min 0 and max 36; higher = better outcome Participant is asked to draw the figure from memory after a 20 minute delay (other tasks completed during this time).

    Figure has 18 units; Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, .5 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per unit.



Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    BDI; 21 item Questionnaire; Mood. With min 0 and max 63; 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3

  2. PCL-Civilian Survey [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Post Traumatic Stress Disorder 17-item, symptom questionnaire; higher scores indicates greater endorsement of symptoms with min 17 and max 85; Reliable decrease 5-10; Clinically meaningful decrease 10-20 points (Monson et al., 2008); Lower scores = better outcome Score ranges from 1-5 for each item.

  3. Visual Analog Pain Rating [ Time Frame: within 1-2 weeks of LED treatment, within 1 Week and 1 Month after the last LED treatment ]
    Visual Analog Pain Rating Scale (VAS); Current Pain Rating scale of 1-10; lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

  4. Short Form McGill Pain Questionnaire [ Time Frame: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Short Form McGill Pain Questionnaire; Pain Rating (for the last 30 days) with min 0 and max 45; lower = better outcome Participant rates 15 types of pain (None = 0, mild = 1, moderate = 2, severe = 3). Totaled for all types of pain.

  5. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Global Sleep Score with min score of 0 and max score of 27; lower score = better outcome 9 item questionnaire- make up 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) with a min of 0 and max of 3 per component. Global score is total of the 7 component scores.

  6. Karolinska Sleepiness Scale [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Measure of Sleepiness; Participant indicates current level of sleepiness on a scale of 0 extremely alert to 10 extremely sleepy; lower score = better outcome

  7. Short Form-36V Plus (PCS) [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    36 Question General Health Survey/Questionnaire for Veterans; Physical Composite Score (PCS) measures endorsement of physical health symptoms related to physical problems which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower = better outcome.

  8. Short Form-36V Plus (MCS) [ Time Frame: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment ]
    36 Question General Health Survey/Questionnaire for Veterans; Mental Composite Score (MCS) measures endorsement of mental health symptoms which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower score is better (based on scoring of the Veterans RAND 36 item Health Survey (SV-36) formerly Veterans SF-36.

  9. Multidimensional Fatigue Inventory (MFI), General Score [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Measures General Fatigue Levels; lower = better; General Fatigue Subscale = sum of items numbers 1, 5, 12 and 16 (max = 5, min =0 for each item) Max possible sum is 20.

  10. Multidimensional Fatigue Inventory, Physical Score [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Physical Score Subscale Measures Physical Fatigue Levels; lower = better outcome; sum of items numbers 2, 8, 14 and 20 (max = 5, min =0 for each item)

  11. Multidimensional Fatigue Inventory, Reduced Activity Score [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Reduced Activity Subscale measures fatigue levels during activity; lower = better outcome; sum of items numbers 3, 6, 10 and 17 (max = 5, min =0 for each item) Max possible sum is 20.

  12. Multidimensional Fatigue Inventory, Reduced Motivation Activity [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Reduced Motor Activity subscale measures if fatigue affects motivation levels; lower score = better outcome; sum of items numbers 4, 9, 15, and 18 (max = 5, min =0 for each item) Max possible sum is 20.

  13. Multidimensional Fatigue Inventory, Mental Fatigue [ Time Frame: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment ]
    Mental Fatigue subscale measures mental fatigue levels; lower = better outcome; sum of items numbers 7, 11, 13 and 19 (max = 5, min =0 for each item) Max possible sum is 20.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   38 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants were recruited from the participants in a Department of Defense (DoD) study of a longitudinal cohort of Gulf War Veterans who returned from their deployment in 1991 through Ft. Devens, MA. This cohort has been followed at multiple time points since the end of war (Proctor et al., 1998), and through the VA Informatics and Computing Infrastructure (VINCI)/Corporate Data Warehouse (CDW) database, with approval from NDS. The San Francisco VA Medical Center (SF VAMC) was a second site on the study (35 Veterans were run in Boston; 12 were run in San Francisco on the same protocol.)

Those recruited from the VINCI/CDW database, resided within a 25 mile radius of the Boston VA Healthcare System (VABHS) or 25 miles of the SF VA Medical Center (VAMC). The Institutional Review Board at the VA BHS and the SF VAMC (University of California, San Francisco) approved the study. In accordance with the Declaration of Helsinki, Informed Consent and HIPAA authorization was obtained from all participants.

Participants answered 'Yes' to the following questions: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information.

  • Must be a Veteran deployed in 1990-1991 Gulf War, in the Kuwait Theatre
  • Meets criteria for GWVI as defined by "Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998). Participants must have the presence of 1 or more chronic symptoms (lasting >6 months) from at least 2 of 3 symptom categories from Fukuda et al., (1998): 1) musculoskeletal (muscle pain, or joint pain, stiffness); 2) mood-cognition 3) fatigue.
  • Ages 38 - 65 years
  • Must be physically able to travel to the VA Boston Healthcare System, Jamaica Plain or San Francisco VA Medical Center, for Neuropsychological testing and transcranial LED treatments
  • Must meet screening criteria from the Eligibility Screening:

The following Neuropsychological (NP) tests were administered at Screening: Trail Making Test A & B (Reynolds, 2002); Controlled Oral Word Association Test (COWAT (FAS); Spreen & Benton, 1977; Benton and Hamsher, 1989); California Verbal Learning Test - II (Delis et al., 2000); Color-Word Interference Test (Stroop; Delis, Kaplan, Kramer, 2001). Additional screening tests included: Short Form McGill Pain Questionnaire (Melzac, 1984); Overall VAS current pain rating (0-10); and the PTSD Checklist- Civilian (PCL-C, Weathers et al., 1994).

Participants were required to score at least 2 SD below the standardized norm (age, education, gender) on at least 1 NP screening test or 1 SD below the standardized norm on at least 2 NP screening tests. The Word Reading Subtest from the Wide Range Achievement Test-4 (Wilkinson and Robertson, 2006) was used to estimate premorbid level of cognitive functioning. The SD for each participant on each NP screening test was adjusted by his/her estimated premorbid cognitive level.

The Test of Memory Malingering (TOMM, 1996) was administered. Participants who failed Trial 2, or Trial 1 and 2 were excluded from the study. If a participant failed Trial 1, but did not fail Trial 2, he/she was not excluded if he/she showed evidence of poor learning on other NP screening tests such as the CVLT (Schroeder et al., 2013, Arch Clin Neuropsych) Participants were required to have a level of pain 7/10 or less on the VAS and less than 38/50 on the McGill pain questionnaires at screening, as pain has been shown to influence cognition (Moriarty et al., 2011, Review).

Exclusion Criteria:

  • Presence of a neurodegenerative disease such as ALS, Parkinson's, Dementia
  • Presence of a life-threatening disease such as cancer
  • Presence of a severe mental disorder such as schizophrenia, or bipolar depression (not associated with PTSD)
  • Current substance abuse or active treatment within last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782378


Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Margaret Naeser, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Principal Investigator: Linda L Chao, PhD San Francisco VA Medical Center, San Francisco, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01782378    
Other Study ID Numbers: SPLD-014-12S
1I01CX000524-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2013    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Gulf War Veterans Illness
Veterans Health
Executive Function
Memory
Attention
Cognition
Laser Therapy, Low-Level
Phototherapy
Light Therapy
Depression
Light-Emitting Diodes
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms