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Cognitive Enhancement Through Transcranial Laser Therapy (LLLT)

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ClinicalTrials.gov Identifier: NCT02851173
Recruitment Status : Unknown
Verified February 2019 by Andreana P. Haley, University of Texas at Austin.
Recruitment status was:  Recruiting
First Posted : August 1, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Andreana P. Haley, University of Texas at Austin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Participants Mild Cognitive Impairment Device: LLLT Device: Placebo Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Enhancement Through Transcranial Laser Therapy
Actual Study Start Date : February 21, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: LLLT
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
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).
Active Comparator: Placebo
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Psychomotor vigilance task (PVT) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. BOLD response to working memory task (2 back task) [ Time Frame: 8 weeks ]
  2. Working memory (2 back task) [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02851173


Contacts
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Contact: Andreana Haley, Ph.D. 512-232-0863 haley@austin.utexas.edu
Contact: Francisco Gonzalez-Lima, Ph.D. 512-471-5895 gonzalezlima@utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Andreana Haley, Ph.D.    512-471-7926    neurolab.ut@gmail.com   
Principal Investigator: Andreana Haley, PhD         
Principal Investigator: Hirofumi Tanaka, PhD         
Principal Investigator: Francisco Gonzalez-Lima, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Andreana Haley, Ph.D. The University of Texas at Austin
More Information
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Responsible Party: Andreana P. Haley, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02851173    
Other Study ID Numbers: 2015-09-0018
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders