Back to resultsCognitive Enhancement Through Transcranial Laser Therapy (LLLT)
Primary Purpose
Healthy Participants, Mild Cognitive Impairment
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LLLT
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Participants
Eligibility 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
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LLLT
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
The outcome represents a score on a scale - brain activation in response to a working memory task (t-statistic). The range is approximately -15 to +15. Positive scores reflect greater engagement of working memory brain regions and better performance.
Working Memory (2 Back Task)
2Back task performance (%Correct)
Working Memory (2 Back Task)
2Back task performance (Reaction Time in msec)
Full Information
NCT ID
NCT02851173
First Posted
July 27, 2016
Last Updated
September 14, 2023
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT02851173
Brief Title
Cognitive Enhancement Through Transcranial Laser Therapy
Acronym
LLLT
Official Title
Cognitive Enhancement Through Transcranial Laser Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2016 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LLLT
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
LLLT
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychomotor Vigilance Task (PVT)
Description
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 Frame
Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.
Secondary Outcome Measure Information:
Title
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
Description
The outcome represents a score on a scale - brain activation in response to a working memory task (t-statistic). The range is approximately -15 to +15. Positive scores reflect greater engagement of working memory brain regions and better performance.
Time Frame
T1 represents score at baseline; T2 represents follow-up score, 6 weeks later
Title
Working Memory (2 Back Task)
Description
2Back task performance (%Correct)
Time Frame
T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later
Title
Working Memory (2 Back Task)
Description
2Back task performance (Reaction Time in msec)
Time Frame
T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreana Haley, Ph.D.
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cognitive Enhancement Through Transcranial Laser Therapy
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