Cognitive Enhancement Through Transcranial Laser Therapy (LLLT)

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Mild Cognitive Impairment; Healthy Participants

Treatments: Device: LLLT; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02851173

2015-09-0018

Details and patient eligibility

About

This is a mechanism-driven translational project to test the efficacy of transcranial low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and older adults and participants with Mild Cognitive Impairment.

Full description

The goal of this project is to test the efficacy of LLLT to enhance neurocognitive function in middle-aged adults and examine the modulating influences of carotid atherosclerosis. The specific aims will be accomplished in a randomized controlled trial (RCT) by examining cognitive test performance and blood oxygen level-dependent (BOLD) response to a working memory task in middle-aged and older adults and participants with Mild Cognitive Impairment pre- and post- six-week long intervention of LLLT or placebo. In addition, the investigators will examine if carotid artery intima-media thickness (IMT) moderates the therapeutic effects of LLLT.

Enrollment: 91 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and postmenopausal women, aged 45 and older
• Participants with Mild Cognitive Impairment

Exclusion criteria

• neurological disease (e.g., large vessel stroke, seizure disorder, Parkinson's disease, Alzheimer's disease, clinically significant traumatic brain injury with loss of consciousness > 30 minutes, multiple sclerosis, or brain infection/meningitis
• baseline IQ < 85 placing them below the average range of intellectual functioning
• major psychiatric illness (e.g., schizophrenia, bipolar disorder) or substance abuse (diagnosed abuse and/or previous hospitalization for substance abuse)
• severe cardiovascular disease (e.g., pacemaker), chronic obstructive pulmonary disease, liver or kidney disease, inflammatory illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

LLLT

Experimental group

Description:

Six weekly sessions of LLLT. The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). Each laser stimulation session will consist of total 8 min, with eight 1 min/cycle treatments alternating between two locations on the right forehead.

Treatment:

Device: LLLT

Placebo

Active Comparator group

Description:

The control group will undergo the same procedure as the treatment group, but will receive brief (5-s) stimulation to the intended site on the forehead, followed by 55 s of no stimulation, for each 1-min cycle. Thus the control group will receive approximately 1/12th of the cumulative energy density as the treatment group. This is sufficient to provide a brief sensation of slight heat (as active placebo) at the onset of each one-minute cycle, using a fraction of the energy received by the experimental group.

Treatment:

Device: Placebo