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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Digit Span Forwards
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Digit Span Backwards
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Digit Span Total Forward + Backwards
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Trails Condition 2
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Trails Condition 4
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Stroop Inhibition (Trial 3)
Timeframe: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series
Stroop Inhibition/Switching
Timeframe: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series
California Verbal Learning Test -II (CVLT-II) Total Trials 1-5
Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment
CVLT-II, Short Delay Free Recall
Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment
CVLT-II, Short Delay Cued Recall
Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment
CVLT-II Long Delay Free Recall
Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment
CVLT-II Long Delay Cued Recall
Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment
Conner's Continuous Performance Test II (CPT) False Alarms
Timeframe: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment
CPT Correct Detections, Reaction Time (RT)
Timeframe: 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'
Timeframe: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment
Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment
ROCFT, Delayed Recall
Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment