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Trial record 40 of 314 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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Moderate Traumatic Brain Injury (TBI) Device: Active LLLT helmet application Device: Non-active LLLT helmet application Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Non-active LLLT helmet application
LED helmet applied without light activated

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
Device: Active LLLT helmet application
LED helmet applied with light activated




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neuroreactivity of light therapy to the injured brain based on MRI [ Time Frame: up to 12 months after treatment ]
    Quantitative MRI metrics.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233413


Contacts
Contact: Rajiv Gupta, MD, PhD 617-726-8354

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rajiv Gupta, MD, PhD    617-726-8354      
Principal Investigator: Rajiv Gupta, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Rajiv Gupta, MD, PhD Massachusetts General Hospital
Study Director: Benjamin Vakoc, PhD Massachussetts General Hospital

Responsible Party: Rajiv Gupta, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02233413     History of Changes
Other Study ID Numbers: 2013P000430
W81XWH-13-2-0067 CDMRP ( Other Grant/Funding Number: Department of Defense )
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Keywords provided by Rajiv Gupta, Massachusetts General Hospital:
Traumatic brain injury
TBI
Low-level light therapy
LLLT
LLLT helmet

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System