At a glance

ClinicalIndex Comparison Record

N/ACompleted· 96 enrolled

Drug / intervention

Real LED Treatment +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01782378

NCT01782378N/ACompleted

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Transcranial, Light-Emitting Diode (LED) Therapy to Improve Cognition in GWVI

VA Office of Research and Development·interventional·Posted Feb 1, 2013·Updated Jan 22, 2020

In Brief

A clinical study evaluating Real LED Treatment and Sham LED Treatment for Gulf War Veterans Illness and 2 related conditions. Completed, enrolled 96 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGulf War Veterans Illness, Neurobehavioral Manifestations, Memory Disorders

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedFeb 2013

Enrollment StartJan 2015

Primary CompletionAug 2018

TodayJul 2026

First PostedFeb 1, 2013

Enrollment StartJan 9, 2015

Primary CompletionAug 6, 2018

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 13.4 years ago

Interventions

Real LED Treatmentdevice

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

Sham LED Treatmentdevice

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