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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | T1 represents score at baseline; T2 represents follow-up score, 6 weeks later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreana Haley, Ph.D. | The University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Austin | Texas | 78712 | United States |
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641 participants were screened, 155 passed initial phone screening, 91 were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Cognitively unimpaired (CU) participants were analyzed separately from the Mild Cognitive Impairment (MCI) participants. One participant was missing data on T1 and 2 participants were missing data on T2 due to equipment failure. | Posted | Mean | Standard Deviation | msec | Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later. |
|
Information about adverse events was collected for the duration of the study (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | 24 hours post screening blood draw, participant reported floating pain (started in the arm, moved to back, and "haunches") |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andreana Haley | University of Texas at Austin | 512-232-0863 | haley@austin.utexas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Mar 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2014 | Mar 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 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. |
|
| Working Memory (2 Back Task) | 2Back task performance (%Correct) | T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later |
| Working Memory (2 Back Task) | 2Back task performance (Reaction Time in msec) | T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Missing data | Mean | Standard Deviation | msec |
|
| OG001 | 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. 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. |
|
|
|
| Secondary | 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. | No data were collected on the secondary outcome variables from participants with Mild Cognitive Impairment (MCI) per study design as this task is too difficult for people with cognitive impairment. Two participants were missing T1 data due to equipment failure; 2 participants were missing T2 due to equipment failure. | Posted | Mean | Standard Deviation | score on a scale | T1 represents score at baseline; T2 represents follow-up score, 6 weeks later |
|
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|
|
| Secondary | Working Memory (2 Back Task) | 2Back task performance (%Correct) | No data were collected on the secondary outcome variables from participants with Mild Cognitive Impairment (MCI) per study design as this task is generally too difficult for patients with cognitive impairment. Data were missing on 7 participants at T1 and 9 participants on T2 due to equipment failure. | Posted | Mean | Standard Deviation | % correct responses of total responses | T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later |
|
|
|
|
| Secondary | Working Memory (2 Back Task) | 2Back task performance (Reaction Time in msec) | No data were collected on the secondary outcome variables from participants with Mild Cognitive Impairment (MCI) per study design as this task is generally too difficult for people with cognitive impairment. Data were missing on 10 participants at T1 and 13 participants on T2 due to equipment failure. | Posted | Mean | Standard Deviation | msec | T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | 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. 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. | 0 | 47 | 0 | 47 | 2 | 47 |
|
| headache | Nervous system disorders | Systematic Assessment | participant reported headaches, judged to be related to an unrelated medical condition |
|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
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| CU T2 Left middle frontal gyrus 1. |
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| CU T1 Left medial frontal/superior frontal gyrus. |
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| CU T2 Left medial frontal/superior frontal gyrus. |
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| CU T1 Right superior parietal lobule. |
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| CU T2 Right superior parietal lobule. |
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| CU T1 Left inferior parietal lobule. |
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| CU T2 Left inferior parietal lobule. |
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| CU T1 Left middle frontal gyrus 2. |
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| CU T2 Left middle frontal gyrus 2. |
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| CU T1 Right superior frontal gyrus. |
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| CU T2 Right superior frontal gyrus. |
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| CU T1 Right middle frontal gyrus. |
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| CU T2 Right middle frontal gyrus. |
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| CU T1 Right inferior frontal gyrus. |
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| CU T2 Right inferior frontal gyrus. |
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| ANOVA |
| 0.69 |
| Other |
| The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule. | ANOVA | 0.25 | Other |
| The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule. | ANOVA | 0.86 | Other |
| The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2. | ANOVA | 0.28 | Other |
| The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus. | ANOVA | 0.12 | Other |
| The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus. | ANOVA | 0.26 | Other |
| The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus. | ANOVA | 0.83 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Left middle frontal gyrus 1. | ANOVA | 0.55 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Left medial frontal/superior frontal gyrus. | ANOVA | 0.76 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Right superior parietal lobule. | ANOVA | 0.38 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Left inferior parietal lobule. | ANOVA | 0.93 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Left middle frontal gyrus 2. | ANOVA | 0.41 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Right superior frontal gyrus. | ANOVA | 0.06 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Right middle frontal gyrus. | ANOVA | 0.18 | Other |
| The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (>50% accuracy). Right inferior frontal gyrus. | ANOVA | 0.84 | Other |
| CU %Correct T2 |
|
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| ANOVA |
| 0.74 |
| Other |
| CU RT T2 |
|
|
| ANOVA |
| 0.97 |
| Other |