Trial Outcomes & Findings for Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD) (NCT NCT03209882)
NCT ID: NCT03209882
Last Updated: 2021-07-23
Results Overview
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
7 weeks
Results posted on
2021-07-23
Participant Flow
31 veterans were screened for eligibility between October, 2017 and November, 2018. Ten veterans met the inclusion criteria, among them nine completed the study, and one quit after the initial screening for family reason.
All of the nine participants were randomly assigned into the two arms.
Participant milestones
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
Participants first received a sham session, followed by six weekly TILS sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
n=6 Participants
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
n=3 Participants
Participants first received a sham session, followed by six weekly TILS sessions.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
36.33 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksCerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Outcome measures
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
n=6 Participants
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
n=3 Participants
Participants first received a sham session, followed by six weekly TILS sessions.
|
|---|---|---|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to sham
|
0.09 microMolar/L
Standard Deviation 0.21
|
-0.33 microMolar/L
Standard Deviation 0.58
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 1st TILS
|
0.13 microMolar/L
Standard Deviation 0.23
|
0.70 microMolar/L
Standard Deviation 1.22
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 2nd TILS
|
0.03 microMolar/L
Standard Deviation 0.27
|
1.44 microMolar/L
Standard Deviation 2.58
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 3rd TILS
|
0.04 microMolar/L
Standard Deviation 0.26
|
2.39 microMolar/L
Standard Deviation 4.18
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 4th TILS
|
-0.12 microMolar/L
Standard Deviation 0.57
|
0.86 microMolar/L
Standard Deviation 1.75
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 5th TILS
|
0.08 microMolar/L
Standard Deviation 0.23
|
0.47 microMolar/L
Standard Deviation 1.01
|
|
Cerebral CCO Changes in Response to TILS and Sham
Average CCO changes in response to 6th TILS
|
0.09 microMolar/L
Standard Deviation 0.13
|
1.03 microMolar/L
Standard Deviation 1.78
|
PRIMARY outcome
Timeframe: 7 weeksCerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session
Outcome measures
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
n=6 Participants
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
n=3 Participants
Participants first received a sham session, followed by six weekly TILS sessions.
|
|---|---|---|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to sham
|
0.40 microMolar/L
Standard Deviation 0.26
|
-0.95 microMolar/L
Standard Deviation 1.85
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to sham
|
0.28 microMolar/L
Standard Deviation 1.76
|
-1.12 microMolar/L
Standard Deviation 2.56
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 1st TILS
|
2.80 microMolar/L
Standard Deviation 1.71
|
2.77 microMolar/L
Standard Deviation 5.13
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 1st TILS
|
0.08 microMolar/L
Standard Deviation 0.47
|
1.66 microMolar/L
Standard Deviation 2.03
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 2nd TILS
|
3.08 microMolar/L
Standard Deviation 1.57
|
3.58 microMolar/L
Standard Deviation 3.97
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 2nd TILS
|
0.37 microMolar/L
Standard Deviation 0.27
|
2.52 microMolar/L
Standard Deviation 3.53
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 3rd TILS
|
3.97 microMolar/L
Standard Deviation 1.44
|
2.60 microMolar/L
Standard Deviation 2.43
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 3rd TILS
|
0.12 microMolar/L
Standard Deviation 0.21
|
3.37 microMolar/L
Standard Deviation 5.42
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 4th TILS
|
2.92 microMolar/L
Standard Deviation 2.19
|
2.77 microMolar/L
Standard Deviation 3.01
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 4th TILS
|
0.21 microMolar/L
Standard Deviation 0.48
|
1.89 microMolar/L
Standard Deviation 3.51
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 5th TILS
|
2.44 microMolar/L
Standard Deviation 1.23
|
3.05 microMolar/L
Standard Deviation 1.45
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 5th TILS
|
0.64 microMolar/L
Standard Deviation 0.54
|
1.04 microMolar/L
Standard Deviation 2.26
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average oxy-Hb change in response to 6th TILS
|
2.73 microMolar/L
Standard Deviation 1.60
|
4.93 microMolar/L
Standard Deviation 4.10
|
|
Cerebral Hemodynamic Changes in Response to TILS and Sham
Average deoxy-Hb change in response to 6th TILS
|
0.07 microMolar/L
Standard Deviation 0.65
|
1.31 microMolar/L
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: 8 weeksThe participant's recall time in Digit Forward (DF) task and Digit Backward (DB) task was recorded recorded during initial baseline, and after the one sham and six TILS sessions. The recall time indicates how fast the participants could recall that digital numbers 10 seconds after they vanished on computer screen.
Outcome measures
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
n=6 Participants
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
n=3 Participants
Participants first received a sham session, followed by six weekly TILS sessions.
|
|---|---|---|
|
Short-term Memory Scores
DF recall time, baseline
|
7.1 second
Standard Deviation 2.9
|
6.5 second
Standard Deviation 3.4
|
|
Short-term Memory Scores
DB recall time, baseline
|
10.8 second
Standard Deviation 4.8
|
9.5 second
Standard Deviation 3.7
|
|
Short-term Memory Scores
DF recall time, sham
|
5.4 second
Standard Deviation 1.3
|
5.7 second
Standard Deviation 2.5
|
|
Short-term Memory Scores
DB recall time, sham
|
8.1 second
Standard Deviation 2.7
|
8.6 second
Standard Deviation 3.3
|
|
Short-term Memory Scores
DF recall time, 1st TILS
|
6.1 second
Standard Deviation 2.3
|
5.9 second
Standard Deviation 3.3
|
|
Short-term Memory Scores
DB recall time, 1st TILS
|
8.4 second
Standard Deviation 2.9
|
9.9 second
Standard Deviation 6.9
|
|
Short-term Memory Scores
DF recall time, 2nd TILS
|
5.6 second
Standard Deviation 1.4
|
5.9 second
Standard Deviation 2.8
|
|
Short-term Memory Scores
DB recall time, 2nd TILS
|
8.4 second
Standard Deviation 2.7
|
9.2 second
Standard Deviation 5.8
|
|
Short-term Memory Scores
DF recall time, 3rd TILS
|
5.2 second
Standard Deviation 1.1
|
5.9 second
Standard Deviation 3.5
|
|
Short-term Memory Scores
DB recall time, 3rd TILS
|
7.4 second
Standard Deviation 1.7
|
11.1 second
Standard Deviation 7.3
|
|
Short-term Memory Scores
DF recall time, 4th TILS
|
5.0 second
Standard Deviation 1.0
|
6.3 second
Standard Deviation 3.1
|
|
Short-term Memory Scores
DB recall time, 4th TILS
|
6.3 second
Standard Deviation 1.0
|
7.9 second
Standard Deviation 5.0
|
|
Short-term Memory Scores
DF recall time, 5th TILS
|
5.1 second
Standard Deviation 0.9
|
5.6 second
Standard Deviation 3.4
|
|
Short-term Memory Scores
DB recall time, 5th TILS
|
6.2 second
Standard Deviation 1.2
|
8.5 second
Standard Deviation 5.5
|
|
Short-term Memory Scores
DF recall time, 6th TILS
|
4.9 second
Standard Deviation 0.6
|
5.7 second
Standard Deviation 3.3
|
|
Short-term Memory Scores
DB recall time, 6th TILS
|
6.5 second
Standard Deviation 1.5
|
7.9 second
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 8 weeksAnterior prefrontal hemodynamic activations (HbO2 and Hb changes) measured by functional NIRS during the Digit Forward (DF) and Digit Backward (DB) tasks. The activations were recorded from initial baseline, and after the one sham and six TILS sessions. In post-experiment processing, the activations were averaged in the recall phase, which was a key component related to PTSD.
Outcome measures
| Measure |
One TILS, One Sham, and Then Five TILS Interventions
n=6 Participants
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
|
One Sham, Then Six TILS Interventions
n=3 Participants
Participants first received a sham session, followed by six weekly TILS sessions.
|
|---|---|---|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 5th TILS
|
-2.8 microMolar/L
Standard Deviation 3.5
|
0.6 microMolar/L
Standard Deviation 3.0
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, baseline
|
0.5 microMolar/L
Standard Deviation 2.2
|
0.5 microMolar/L
Standard Deviation 1.4
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, baseline
|
-0.4 microMolar/L
Standard Deviation 0.4
|
-0.8 microMolar/L
Standard Deviation 1.5
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, baseline
|
1.4 microMolar/L
Standard Deviation 2.2
|
-0.5 microMolar/L
Standard Deviation 2.0
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, baseline
|
0.7 microMolar/L
Standard Deviation 1.0
|
0.3 microMolar/L
Standard Deviation 0.5
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, sham
|
-0.6 microMolar/L
Standard Deviation 3.1
|
-2.3 microMolar/L
Standard Deviation 1.7
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, sham
|
0.0 microMolar/L
Standard Deviation 0.7
|
-0.3 microMolar/L
Standard Deviation 0.4
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, sham
|
-1.1 microMolar/L
Standard Deviation 2.7
|
-0.7 microMolar/L
Standard Deviation 1.1
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, sham
|
-0.1 microMolar/L
Standard Deviation 1.2
|
0.2 microMolar/L
Standard Deviation 0.4
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 1st TILS
|
0.0 microMolar/L
Standard Deviation 2.0
|
-1.2 microMolar/L
Standard Deviation 1.3
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 1st TILS
|
0.0 microMolar/L
Standard Deviation 0.5
|
0.1 microMolar/L
Standard Deviation 0.5
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 1st TILS
|
-2.5 microMolar/L
Standard Deviation 4.0
|
-1.4 microMolar/L
Standard Deviation 4.4
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 1st TILS
|
-0.5 microMolar/L
Standard Deviation 1.3
|
0.4 microMolar/L
Standard Deviation 1.1
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 2nd TILS
|
-2.6 microMolar/L
Standard Deviation 0.8
|
0.8 microMolar/L
Standard Deviation 3.8
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 2nd TILS
|
-0.1 microMolar/L
Standard Deviation 0.6
|
-1.1 microMolar/L
Standard Deviation 2.6
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 2nd TILS
|
1.0 microMolar/L
Standard Deviation 2.0
|
3.9 microMolar/L
Standard Deviation 9.6
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 2nd TILS
|
0.7 microMolar/L
Standard Deviation 1.1
|
2.2 microMolar/L
Standard Deviation 3.5
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 3rd TILS
|
-1.0 microMolar/L
Standard Deviation 1.7
|
0.6 microMolar/L
Standard Deviation 4.0
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 3rd TILS
|
-0.2 microMolar/L
Standard Deviation 0.3
|
0.8 microMolar/L
Standard Deviation 0.2
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 3rd TILS
|
-3.3 microMolar/L
Standard Deviation 2.2
|
-1.0 microMolar/L
Standard Deviation 1.0
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 3rd TILS
|
-1.1 microMolar/L
Standard Deviation 1.1
|
0.1 microMolar/L
Standard Deviation 0.4
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 4th TILS
|
-1.6 microMolar/L
Standard Deviation 2.8
|
-1.8 microMolar/L
Standard Deviation 1.8
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 4th TILS
|
0.1 microMolar/L
Standard Deviation 0.7
|
0.1 microMolar/L
Standard Deviation 0.3
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 4th TILS
|
-1.3 microMolar/L
Standard Deviation 3.4
|
-1.1 microMolar/L
Standard Deviation 3.7
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 4th TILS
|
-0.1 microMolar/L
Standard Deviation 0.6
|
-0.8 microMolar/L
Standard Deviation 1.0
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 5th TILS
|
-3.2 microMolar/L
Standard Deviation 2.0
|
0.6 microMolar/L
Standard Deviation 2.0
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 5th TILS
|
-0.3 microMolar/L
Standard Deviation 1.0
|
0.4 microMolar/L
Standard Deviation 0.3
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 5th TILS
|
0.2 microMolar/L
Standard Deviation 1.0
|
0.4 microMolar/L
Standard Deviation 0.5
|
|
Prefrontal Activations in Short-term Memory Processing
DF HbO2, 6th TILS
|
-2.0 microMolar/L
Standard Deviation 1.2
|
-0.4 microMolar/L
Standard Deviation 1.5
|
|
Prefrontal Activations in Short-term Memory Processing
DF Hb, 6th TILS
|
-0.1 microMolar/L
Standard Deviation 0.9
|
0.4 microMolar/L
Standard Deviation 0.7
|
|
Prefrontal Activations in Short-term Memory Processing
DB HbO2, 6th TILS
|
0.4 microMolar/L
Standard Deviation 2.9
|
-5.7 microMolar/L
Standard Deviation 8.4
|
|
Prefrontal Activations in Short-term Memory Processing
DB Hb, 6th TILS
|
0.2 microMolar/L
Standard Deviation 1.4
|
0.3 microMolar/L
Standard Deviation 0.3
|
Adverse Events
One TILS, One Sham, and Then Five TILS Interventions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
One Sham, Then Six TILS Interventions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place