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LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans

NCT02356861 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-09

No results posted yet for this study

Summary

The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial, light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front of the head through the scalp. The participants receive a series of LED treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The LEDs contain near-infrared diodes. The FDA considers the LED device used here, to be a non-significant risk device. The LEDs do not produce heat.

Conditions

  • Traumatic Brain Injury (TBI)
  • Post-traumatic Stress Disorder (PTSD)

Interventions

DEVICE

Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on

The LED helmet from Photomedex, Montgomeryville, PA will be used. 18 LED pods are in the helmet. Each LED pod: Pod size: 19 cm2 Power output: 692.5 mW Power density: 36.5 mW/cm2 20 NIR diodes, 830 nm and 4 red diodes, 633 nm. 1 J/cm2 = 30.4 sec

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jeffrey A Knight, PhD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356861 on ClinicalTrials.gov