Cognitive Enhancement Through Transcranial Laser Therapy

NCT02851173 | Completed Phase 2 Results DMC

• 1 other identifier: 2015-09-0018
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Psychomotor Vigilance Task (PVT)

  The psychomotor vigilance task (PVT) is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.

  Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.

Secondary Outcomes (3)

• Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task

  T1 represents score at baseline; T2 represents follow-up score, 6 weeks later

• Working Memory (2 Back Task)

  T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later

• Working Memory (2 Back Task)

  T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later

Study Arms (2)

LLLT

EXPERIMENTAL

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.

Device: LLLT

Placebo

ACTIVE COMPARATOR

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.

Device: Placebo

Interventions

LLLT DEVICE

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).

LLLT

Placebo DEVICE

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). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group.

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Andreana Haley
• Organization: University of Texas at Austin

haley@austin.utexas.edu

512-232-0863

Study Officials

• Andreana Haley, Ph.D.

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 1, 2016
• Study Start: February 21, 2016
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2023-09

Locations

US (1)