LED Light Therapy to Improve Cognitive/Psychosocial Function in TBI-PTSD Veterans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001)
Study Overview
Brief 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.
Detailed Description
Rationale:
The rational for using near-infrared LEDs is two-fold: 1) These wavelengths have been shown to improve adenosine triphosphate (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. The helmet contains some light-emitting diodes (LEDs). The LEDs are not visible (near-infrared wavelengths of light).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
the design included double blind procedures for study staff and participants. study devices were be: 1) an active LED helmet that delivered therapeutic frequencies of light and 2) and identical helmet in all ways except it did not deliver therapeutic frequencies of light
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •The participants for this study will be recruited from flyers posted within the VA Boston Healthcare System and Veterans who contact the study after hearing about it from an outside referral source who knows that the study is actively recruiting participants. Participants must have both mild or moderate TBI and PTSD
- •Males or Females; Ages 18 - 65 years old
- •Must live within 50 miles of and 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
- •Must meet screening criteria for a PTSD diagnosis
Exclusion Criteria
- •Exclusion Criteria:
- •Not meeting criteria for post-traumatic stress disorder and for mild or moderate traumatic brain injury
- •Had Gulf War Veterans' Illnesses (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 18, or greater than age 60
- •Presence of a neurodegenerative disease such as Amyotrophic Lateral Sclerosis (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 in active treatment
- •Did not meet screening criteria from the Neuropsychological Screening Tests
- •does not reside physically within 50 miles of the VA Boston - Jamaica Plain VA Hospital location
Arms & Interventions
Real, Active LED Treatment Series
These participants will first receive a series of 12, sham LED treatments, At 1 week post completion of the Sham LED treatment series, participants in this group receive a series of 12 real LED treatments from the helmet housing LEDs that deliver photons of light in the infrared range.
Intervention: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on (Device)
Sham LED Treatment Series
These participants will first receive an initial series of 12 sham LED treatments from the helmet containing the sham LEDs.
Intervention: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on (Device)
Outcomes
Primary Outcomes
Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001)
Time Frame: 1 Week after the last LED treatment in each treatment series
Attention/Executive Function
Secondary Outcomes
- California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)(1 Week after the last LED treatment in each treatment series)
- Digit Span Subtests (WAIS-IV; Wechsler, 2008) D-KEF Trails (Delis, Kaplan & Kramer, 2001)(1 Week after the last LED treatment in each treatment series)
- Beck Depression inventory (BDI; Beck, 2006)(2 Months after the last LED treatment)
- hort Form-36V Plus (Ware et al., 2000) Health Symptom Checklist (HSC).(2 Months after the last LED treatment)