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NCT01782378 · ClinicalTrials.gov registry record · NA
Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT01782378: Completed NA study, sponsored by VA Office of Research and Development.
NCT01782378 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01782378, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Real LED Treatment
- DEVICE Sham LED Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2015-01-09 |
| Est. Completion | 2018-08-06 |
| Phase | NA |
What the finished NCT01782378 record still lists
NCT01782378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Real LED Treatment is the first listed.
NCT01782378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01782378 about?
NCT01782378 is a clinical study titled "Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness". 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 wit...
What is the current status of trial NCT01782378?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2015-01-09. Estimated completion is 2018-08-06.
What interventions are being tested in trial NCT01782378?
The interventions under investigation include: Real LED Treatment (DEVICE), Sham LED Treatment (DEVICE).
Who is sponsoring clinical trial NCT01782378?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01782378's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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