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Light Therapy for Moderate Traumatic Brain Injury

NCT ID: NCT02233413

Last Updated: 2020-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Moderate Traumatic Brain Injury (TBI)

Keywords

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Traumatic brain injury TBI Low-level light therapy LLLT LLLT helmet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

Non-active LLLT helmet application

Intervention Type DEVICE

LED helmet applied without light activated

Active LLLT helmet application

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

Group Type ACTIVE_COMPARATOR

Active LLLT helmet application

Intervention Type DEVICE

LED helmet applied with light activated

Interventions

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Active LLLT helmet application

LED helmet applied with light activated

Intervention Type DEVICE

Non-active LLLT helmet application

LED helmet applied without light activated

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rajiv Gupta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajiv Gupta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Benjamin Vakoc, PhD

Role: STUDY_DIRECTOR

Massachussetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38805733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32926117 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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W81XWH-13-2-0067 CDMRP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2013P000430

Identifier Type: -

Identifier Source: org_study_id