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Summary

Eligibility
for people ages 38–65
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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), to possibly deliver photons to the deeper parts of the brain. 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 LEDs contain red and near-infrared diodes. The FDA considers the LED device used here, to be a non-significant risk device. The LEDs do not produce heat.

Official Title

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

Details

Rationale:

The rational for using red and near-infrared LEDs is two-fold: 1) These wavelengths have been shown to improve ATP production, especially in hypoxic or compromised cells. 2) Recent studies in humans have also shown an increase in regional cerebral blood flow subjacent to where the near-infrared LEDs were placed on the scalp (Schiffer et al., 2009; Nawashiro et al., 2012).

General Explanation of the Light-Emitting Diode (LED) Treatment Procedure:

The LED treatments take place as outpatient visits at the VA Boston Healthcare System (VABHS) Jamaica Plain Campus (JP Campus), 150 South Huntington Ave., Boston, MA, 02130.

The Transcranial LED treatment procedure is painless, non-invasive and no heat is generated. It involves placing a lightweight helmet on the head and intranasal devices in the nostrils. The helmet contains some light-emitting diodes (LEDs). Some of the LEDs are in the visible range of light that one can see (red wavelengths of light); some of the LEDs are not visible (near-infrared wavelengths of light). The participant will be asked to wear some goggles/glasses during each LED treatment. These goggles/glasses will block out the red wavelengths of light, so that the participant will not be aware of when the lights are on, or off.

During some of the LED treatments, the lights are turned on. During some of the LED treatments, the lights are not turned on. All participants who are part of this study will receive some LED treatments when the LED lights are turned on.

The participant will not feel anything when the LED lights are on; it is a painless, noninvasive treatment procedure. There are small fans built into the LED helmet (to assist in cooling). The participant will always hear the fans, during each LED treatment, whether the LEDs are on, or they are not on.

There are 2 sequential parts to each LED treatment visit, while the LED helmet is on the head:

Part 1: The LEDs in the center of the helmet are on for about 14 minutes; then turned off.

Part 2: The LEDs in the left and right side of the helmet are on for about 14 minutes; then off.

During Parts 1 and 2, the intranasal devices are on for about 25 minutes.

The entire treatment with the LED helmet in place on the head is about 30 minutes, per treatment visit. There is no potential for eye damage, because LED light is not a laser light.

The participant will remain in street clothes, and will be treated in a soft recliner chair. Each visit lasts about 35 to 45 minutes, allowing time for record keeping.

No liquids or gel are used to hold the LEDs in place on the head. Each participant will be provided with his/her own clear plastic liner for the LED helmet. This clear plastic liner will be assigned to each participant, and only used by that participant. It will be kept in a locked filing cabinet in the treatment room, and discarded after the participant's completion of the study.

There are 15 visits in each LED treatment series; and each participant will participate in two LED treatment series. Each LED treatment series lasts for 7.5 weeks. Each LED treatment visit is scheduled twice per week, with at least 48 hours between each visit.

All appointments are scheduled ahead, for a specific day and time of day, at the convenience of the participant. If the participant needs to miss an appointment, that appointment will be re-scheduled. However, if the participant misses more than 1 appointment in a row, over a two-week period, he/she will be withdrawn from the study. This is because it is very important to treat at least two times per week for the 7.5 weeks, until all 15 LED treatments have been completed, in each of the two LED treatment series.

The length of time for participation in the actual treatment portion of this study is four months (two treatment periods of about two months, each). The total time of participation including pre- testing, and final follow-up testing at 2 months after the last LED treatment visit, is about 6 months.

This study is sponsored by the Department of Veterans Affairs, Clinical Science Research and Development. There are no potential conflicts of interest associated with this research.

Referral and Screening of Potential Participants:

As mentioned in a separate section on Subjects and Inclusion Criteria, the participants for this study are referred by a Neuropsychologist who has been following Veterans in the New England region who had been deployed to Kuwait in 1990-91. Additional participants may be recruited through other sources. After signing the ICF, at the time of neuropsychological screening, the Gulf War Veterans who are not part of the Fort Devens cohort will be given the "Symptom Questions used to Identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" questionnaire. Qualified participants will have answered 'Yes' to the following questions: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information.

After referral to this study, the potential participant is contacted by telephone, and a description of the full study protocol is explained, including that three blood draws are involved, as well as the time required, and reimbursement for time and effort. After the initial contact by telephone, an initial visit to the VABHS, JP campus may be scheduled with the PI, or someone on her staff. At this time, the entire study will be explained and questions answered. If the potential participant wishes to do so, he/she may sign the Informed Consent Form (ICF) at this first visit.

After the ICF has been signed, an appointment is then scheduled for Neuropsychological Screening testing. These tests measure the ability to think and remember recent information. If results from the Neuropsychological Screening tests show that the potential participant is eligible for entry into this study, an additional appointment is scheduled where Additional Neuropsychological Testing is performed, and Additional Health Information is obtained.

The Additional Neuropsychological Tests also measure the ability to think and remember recent information. These tests take place at the VABHS, JP. They are administered by the neuropsychologist or her staff, and they require a two-hour visit.

During the same two-hour visit, Additional Health Information (paper and pencil) is acquired in the following areas: 1) any pain experienced on a regular basis; 2) fatigue that is experienced on a regular basis; 3) mood (including depression); and 4) questions regarding health - for example, how often in the past 30 days symptoms may have been present from each of nine body systems: cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, and psychological.

The Additional Neuropsychological Tests (and the Additional Health Information) are each acquired four times during participation in the study:

Time 1) Within 1 or 2 weeks before the 1st LED Treatment

Time 2) Within 1 week after the 15th LED treatment in the First Series of LED Treatments

Time 3) Within 1 week after the 15th LED treatment in the Second Series of LED Treatments

Time 4) At 2 months after the 15th LED treatment in the Second Series of LED Treatments

Three Blood Draws

Blood samples (venipuncture from the participant's arm) will be taken at three time points during participation in the study. Each blood draw involves one visit to a Quest Lab located near the participant's home or place of work.

Time Schedule for Blood Draws:

Time 1) Within 1 or 2 weeks before the 1st LED Treatment

Time 2) Within 1 week after the 15th LED treatment, in the 1st LED Treatment Series (7.5 Weeks)

Time 3) Within 1 week after the 15th LED treatment, in the 2nd LED Treatment Series (7.5 Weeks)

In summary, there are a total of 4 visits for the areas of "Additional Neuropsychological Tests and Additional Health Information," and 3 visits to a Quest Lab for the Blood Tests.

Statistical Analyses and Power Statement:

There will be two groups of participants, 80 participants per group.

A score for each of 3 cognitive domains will be analyzed pre- and post- LED intervention:

  1. Attention/Executive Function: Digit Span Subtests (WAIS-IV; Wechsler, 2008); Trail-Making Test (Delis, Kaplan, Kramer, 2001); and Color Word Interference Test (Stroop) (Delis, Kaplan, Kramer, 2001)
  2. Learning and Memory: California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
  3. Psychomotor/Visual Spatial; Continuous Performance Test (Administered on computer; RVisual CPT, NES3) (Letz & Baker, 1988; Rosvold et al., 1956); Rey Osterrieth Complex Figure Test (ROCF) (Knight & Kaplan, 2004)

Power Analysis:

Power was computed under the following assumptions for ANOVA: a) alpha = .05 (1-tail); b) to establish clinical relevance, Cohen's large effect size (.25) was used. Power = .86 to detect a significant between-group difference in change from Baseline to end of Treatment for an interim analysis.

Keywords

Persian Gulf Syndrome Neurobehavioral Manifestations Memory Disorders Veterans Health Executive Function Memory Attention Cognition Laser Therapy, Low-Level Phototherapy Light Therapy Depression

Eligibility

You can join if…

Open to people ages 38–65

The participants for this study will be recruited from the participants in a Department of Defense (DoD) study of a longitudinal cohort of Gulf War Veterans who returned from their deployment in 1991 through Ft. Devens, MA. This cohort has been followed at multiple time points since the end of war.

Participants will have answered 'Yes' to the following questions completed on the cohort survey: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information.

  • Must be a Veteran deployed in 1990-1991 Gulf War
  • Meets criteria for GWVI as defined by "Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998). Participants must have the presence of 1 or more chronic symptoms (lasting>6 months) from at least 2 of 3 symptom categories from Fukuda et al., (1998): 1) musculoskeletal (muscle pain, or joint pain,stiffness); 2) mood-cognition 3) fatigue.
  • Ages 38 - 65 years
  • Must be physically able to travel to the VA Boston Healthcare System, Jamaica Plain,for Neuropsychological testing and transcranial LED treatments
  • Must meet screening criteria from the Neuropsychological Screening Tests

You CAN'T join if...

  • Not meeting criteria for GWVI as defined by Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998).
  • Had GWVI, but did not answer 'Yes' to the following questions: 1) Difficulty concentrating and/or 2) Difficulty remembering recent information, on the Symptom Questionnaire
  • Less than age 38, or greater than age 65
  • Presence of a neurodegenerative disease such as ALS, Parkinson's, Dementia
  • Presence of a life-threatening disease such as cancer
  • Presence of a severe mental disorder such as schizophrenia, or severe depression
  • Physical limitations that would prevent traveling to the VA Boston Healthcare System,Jamaica Plain, for Neuropsychological testing and transcranial LED treatments
  • Current substance abuse or active treatment
  • Did not meet screening criteria from the Neuropsychological Screening Tests

Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA accepting new patients
    Boston, Massachusetts, 02130, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT01782378
Phase
Phase 2
Study Type
Interventional
Last Updated
July 1, 2017
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