NCT02356861

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

5.8 years

First QC Date

February 2, 2015

Last Update Submit

February 24, 2022

Conditions

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

Keywords

treatmentphotobiomodulationVeteransbrain-injuryTBIPTSD

Outcome Measures

Primary Outcomes (1)

  • Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001)

    Attention/Executive Function

    1 Week after the last LED treatment in each treatment series

Secondary Outcomes (4)

  • 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

  • California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)

    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

Study Arms (2)

Real, Active LED Treatment Series

ACTIVE COMPARATOR

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.

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

Sham LED Treatment Series

SHAM COMPARATOR

These participants will first receive an initial series of 12 sham LED treatments from the helmet containing the sham LEDs.

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

Interventions

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

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

Real, Active LED Treatment SeriesSham LED Treatment Series

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticStress Disorders, Post-TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Jeffrey A Knight, PhD

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

March 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)