NCT02233413

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

5.2 years

First QC Date

June 5, 2014

Results QC Date

July 31, 2020

Last Update Submit

November 10, 2020

Conditions

Moderate Traumatic Brain Injury (TBI)

Keywords

Traumatic brain injuryTBILow-level light therapyLLLTLLLT helmet

Outcome Measures

Primary Outcomes (1)

  • Safety and Feasibility of Applying Light Therapy After Moderate TBI

    Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.

    up to seven days after enrollment

Secondary Outcomes (3)

  • Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)

    up to 3 months after treatment

  • Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)

    up to 3 months after treatment

  • Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function

    RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.

Study Arms (2)

Non-active LLLT helmet application

SHAM COMPARATOR

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

Active LLLT helmet application

ACTIVE COMPARATOR

A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated

Device: Active LLLT helmet application

Interventions

Active LLLT helmet applicationDEVICE

LED helmet applied with light activated

Active LLLT helmet application
Non-active LLLT helmet applicationDEVICE

LED helmet applied without light activated

Non-active LLLT helmet application

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Chan ST, Mercaldo N, Figueiro Longo MG, Welt J, Avesta A, Lee J, Lev MH, Ratai EM, Wenke MR, Parry BA, Drake L, Anderson RR, Rauch T, Diaz-Arrastia R, Kwong KK, Hamblin M, Vakoc BJ, Gupta R. Effects of Low-Level Light Therapy on Resting-State Connectivity Following Moderate Traumatic Brain Injury: Secondary Analyses of a Double-blinded Placebo-controlled Study. Radiology. 2024 May;311(2):e230999. doi: 10.1148/radiol.230999.

    PMID: 38805733DERIVED

  • Figueiro Longo MG, Tan CO, Chan ST, Welt J, Avesta A, Ratai E, Mercaldo ND, Yendiki A, Namati J, Chico-Calero I, Parry BA, Drake L, Anderson R, Rauch T, Diaz-Arrastia R, Lev M, Lee J, Hamblin M, Vakoc B, Gupta R. Effect of Transcranial Low-Level Light Therapy vs Sham Therapy Among Patients With Moderate Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2017337. doi: 10.1001/jamanetworkopen.2020.17337.

    PMID: 32926117DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Rajiv Gupta
Organization
Massachusetts General Hospital
rgupta1@mgh.harvard.edu
617-726-0369

Study Officials

  • Rajiv Gupta, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Benjamin Vakoc, PhD

    Massachussetts General Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2014

First Posted

September 8, 2014

Study Start

June 1, 2014

Primary Completion

July 31, 2019

Study Completion

July 1, 2020

Last Updated

December 3, 2020

Results First Posted

December 3, 2020

Record last verified: 2020-11

Locations

US(1)