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

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.

Conditions

• Gulf War Veterans Illness
• Neurobehavioral Manifestations
• Memory Disorders

Interventions

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

DEVICE

Sham LED Treatment

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

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Margaret Naeser, PhD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

• Linda L Chao, PhD · San Francisco VA Medical Center, San Francisco, CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

38 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-09

Primary Completion

2018-08-06

Completion

2018-08-06

Countries

• United States

Study Locations