Trial Outcomes & Findings for Cognitive Enhancement Through Transcranial Laser Therapy (NCT NCT02851173)
NCT ID: NCT02851173
Last Updated: 2023-10-04
Results Overview
The psychomotor vigilance task (PVT) is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.
Results posted on
2023-10-04
Participant Flow
641 participants were screened, 155 passed initial phone screening, 91 were enrolled and randomized.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
47
|
|
Overall Study
COMPLETED
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
LLLT
n=44 Participants
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).
|
Placebo
n=47 Participants
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.
|
Total
n=91 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.4 • n=44 Participants
|
64.4 years
STANDARD_DEVIATION 9.5 • n=47 Participants
|
64.7 years
STANDARD_DEVIATION 8.9 • n=91 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=44 Participants
|
28 Participants
n=47 Participants
|
55 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=44 Participants
|
19 Participants
n=47 Participants
|
36 Participants
n=91 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=44 Participants
|
5 Participants
n=47 Participants
|
10 Participants
n=91 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=44 Participants
|
33 Participants
n=47 Participants
|
67 Participants
n=91 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=44 Participants
|
9 Participants
n=47 Participants
|
14 Participants
n=91 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=91 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
2 Participants
n=91 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=91 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=91 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=44 Participants
|
36 Participants
n=47 Participants
|
73 Participants
n=91 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
2 Participants
n=91 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=44 Participants
|
9 Participants
n=47 Participants
|
14 Participants
n=91 Participants
|
|
Psychomotor Vigilance Task (PVT)
|
338.2 msec
STANDARD_DEVIATION 96.8 • n=40 Participants • Missing data
|
342.8 msec
STANDARD_DEVIATION 53.94 • n=42 Participants • Missing data
|
340.5 msec
STANDARD_DEVIATION 77.4 • n=82 Participants • Missing data
|
PRIMARY outcome
Timeframe: Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.Population: 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.
The psychomotor vigilance task (PVT) is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.
Outcome measures
| Measure |
LLLT
n=40 Participants
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).
|
Placebo
n=43 Participants
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.
|
|---|---|---|
|
Psychomotor Vigilance Task (PVT)
Time 1 CU
|
341.89 msec
Standard Deviation 47.8
|
344.09 msec
Standard Deviation 58.03
|
|
Psychomotor Vigilance Task (PVT)
Time 2 CU
|
331.11 msec
Standard Deviation 62.85
|
330.75 msec
Standard Deviation 45.97
|
|
Psychomotor Vigilance Task (PVT)
Time 1 MCI
|
329.76 msec
Standard Deviation 165.87
|
339.81 msec
Standard Deviation 45.53
|
|
Psychomotor Vigilance Task (PVT)
Time 2 MCI
|
333.94 msec
Standard Deviation 139.73
|
321.19 msec
Standard Deviation 62.40
|
SECONDARY outcome
Timeframe: T1 represents score at baseline; T2 represents follow-up score, 6 weeks laterPopulation: 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.
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.
Outcome measures
| Measure |
LLLT
n=28 Participants
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).
|
Placebo
n=30 Participants
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.
|
|---|---|---|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Left middle frontal gyrus 1.
|
2.47 score on a scale
Standard Deviation 2.59
|
3.00 score on a scale
Standard Deviation 1.54
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Left middle frontal gyrus 1.
|
2.51 score on a scale
Standard Deviation 2.40
|
3.39 score on a scale
Standard Deviation 2.15
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Left medial frontal/superior frontal gyrus.
|
2.90 score on a scale
Standard Deviation 2.22
|
2.67 score on a scale
Standard Deviation 1.36
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Left medial frontal/superior frontal gyrus.
|
3.06 score on a scale
Standard Deviation 2.17
|
2.89 score on a scale
Standard Deviation 2.29
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Right superior parietal lobule.
|
2.50 score on a scale
Standard Deviation 2.47
|
2.81 score on a scale
Standard Deviation 1.72
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Right superior parietal lobule.
|
2.39 score on a scale
Standard Deviation 2.96
|
2.86 score on a scale
Standard Deviation 2.57
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Left inferior parietal lobule.
|
2.87 score on a scale
Standard Deviation 2.39
|
3.46 score on a scale
Standard Deviation 1.71
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Left inferior parietal lobule.
|
3.09 score on a scale
Standard Deviation 2.71
|
3.36 score on a scale
Standard Deviation 2.35
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Left middle frontal gyrus 2.
|
1.80 score on a scale
Standard Deviation 2.11
|
2.02 score on a scale
Standard Deviation 1.60
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Left middle frontal gyrus 2.
|
1.84 score on a scale
Standard Deviation 1.72
|
2.14 score on a scale
Standard Deviation 2.12
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Right superior frontal gyrus.
|
2.26 score on a scale
Standard Deviation 2.36
|
2.50 score on a scale
Standard Deviation 1.59
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Right superior frontal gyrus.
|
1.93 score on a scale
Standard Deviation 2.15
|
2.85 score on a scale
Standard Deviation 2.38
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Right middle frontal gyrus.
|
3.09 score on a scale
Standard Deviation 2.90
|
3.51 score on a scale
Standard Deviation 2.04
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Right middle frontal gyrus.
|
3.31 score on a scale
Standard Deviation 2.80
|
3.89 score on a scale
Standard Deviation 2.86
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T1 Right inferior frontal gyrus.
|
0.72 score on a scale
Standard Deviation 2.00
|
1.19 score on a scale
Standard Deviation 2.13
|
|
Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
CU T2 Right inferior frontal gyrus.
|
1.14 score on a scale
Standard Deviation 2.13
|
1.27 score on a scale
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks laterPopulation: 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.
2Back task performance (%Correct)
Outcome measures
| Measure |
LLLT
n=27 Participants
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).
|
Placebo
n=25 Participants
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.
|
|---|---|---|
|
Working Memory (2 Back Task)
CU %Correct T1
|
73.93 % correct responses of total responses
Standard Deviation 14.57
|
73.54 % correct responses of total responses
Standard Deviation 13.48
|
|
Working Memory (2 Back Task)
CU %Correct T2
|
77.17 % correct responses of total responses
Standard Deviation 14.97
|
79.59 % correct responses of total responses
Standard Deviation 13.01
|
SECONDARY outcome
Timeframe: T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks laterPopulation: 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.
2Back task performance (Reaction Time in msec)
Outcome measures
| Measure |
LLLT
n=26 Participants
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).
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Working Memory (2 Back Task)
CU RT T1
|
1289.19 msec
Standard Deviation 225.72
|
1173.98 msec
Standard Deviation 268.44
|
|
Working Memory (2 Back Task)
CU RT T2
|
1202.89 msec
Standard Deviation 261.49
|
1035.05 msec
Standard Deviation 271.38
|
Adverse Events
LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LLLT
n=44 participants at risk
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).
|
Placebo
n=47 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain
|
0.00%
0/44 • Information about adverse events was collected for the duration of the study (12 weeks)
|
2.1%
1/47 • Number of events 1 • Information about adverse events was collected for the duration of the study (12 weeks)
|
|
Nervous system disorders
headache
|
0.00%
0/44 • Information about adverse events was collected for the duration of the study (12 weeks)
|
2.1%
1/47 • Number of events 1 • Information about adverse events was collected for the duration of the study (12 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place