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Trial record 40 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Light Therapy for Moderate Traumatic Brain Injury (LLLT for TBI)

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ClinicalTrials.gov Identifier: NCT02233413
Recruitment Status : Recruiting
First Posted : September 8, 2014
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Rajiv Gupta, Massachusetts General Hospital

June 5, 2014
September 8, 2014
May 17, 2018
June 2014
December 2018   (Final data collection date for primary outcome measure)
Safety and feasibility of applying light therapy after moderate TBI [ Time Frame: up to seven days after enrollment ]
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
Safety and feasibility of applying light therapy after moderate TBI [ Time Frame: up to seven days after enrollment ]
Number of subjects to successfully complete up to 7 days of light therapy without serious unanticipated adverse events related to application of the device.
Complete list of historical versions of study NCT02233413 on ClinicalTrials.gov Archive Site
  • Neuroreactivity of light therapy to the injured brain based on MRI [ Time Frame: up to 12 months after treatment ]
    Quantitative MRI metrics.
  • Neuroreactivity of light therapy to the injured brain based on neurcognitive function [ Time Frame: up to 12 months after treatment ]
    Neurocognitive function based on clinical exams.
Same as current
Not Provided
Not Provided
 
Light Therapy for Moderate Traumatic Brain Injury
Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
The purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI).
The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the response to LLLT through MR imaging and clinical outcome measures.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Moderate Traumatic Brain Injury (TBI)
  • Device: Active LLLT helmet application
    LED helmet applied with light activated
  • Device: Non-active LLLT helmet application
    LED helmet applied without light activated
  • Sham Comparator: Non-active LLLT helmet application
    A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
    Intervention: Device: Non-active LLLT helmet application
  • Active Comparator: Active LLLT helmet application
    A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
    Intervention: Device: Active LLLT helmet application
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years old;
  • Injury within 72 hours at the time of consent;
  • Head injury requiring hospital admission;
  • A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.

Exclusion Criteria:

  • Need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters);
  • Hemodynamic instability as determined by the clinician;
  • History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia, Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing, hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases, Wernicke-Korsakoff syndrome, and dementia of unknown etiology.
  • Pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study);
  • Electrical implants such as cardiac pacemakers or perfusion pumps;
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, or any other contra-indications to MRI.
  • Clinical determination that subject cannot undergo MRI
  • Breastfeeding
  • Unstable cervical fractures
  • Scalp lacerations or surgical wounds severe enough to preclude safe application of device
  • Unreliable to follow up
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Rajiv Gupta, MD, PhD 617-726-8354
United States
 
 
NCT02233413
2013P000430
W81XWH-13-2-0067 CDMRP ( Other Grant/Funding Number: Department of Defense )
Yes
Not Provided
Not Provided
Rajiv Gupta, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Rajiv Gupta, MD, PhD Massachusetts General Hospital
Study Director: Benjamin Vakoc, PhD Massachussetts General Hospital
Massachusetts General Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP