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Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)

Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03209882
Enrollment
10
Registered
2017-07-06
Start date
2017-10-01
Completion date
2019-10-08
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Transcranial infrared laser stimulation (TILS), Near-infrared spectroscopy (NIRS)

Brief summary

This study evaluates the effects of transcranial infrared laser stimulation (TILS) on prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder (PTSD). The subjects will receive six TILS interventions and one sham intervention in a course of seven weeks.

Detailed description

Post-traumatic stress disorder (PTSD) is often associated with cognitive impairments. It has been indicated that hypoactivity of the prefrontal cortex plays a major role in the disrupted neural circuitry of mood and cognition. Transcranial infrared laser stimulation (TILS) is a neural type of photobiomodulation that can elevate neuronal metabolism by exciting cytochrome c oxidase (CCO). Veterans with PTSD will receive prefrontal TILS interventions once-per-week for six weeks. They will also receive an additional sham intervention (laser power = 0) that will be randomly assigned into the first two sessions. Broadband near-infrared spectroscopy (bbNIRS) will be used to directly assess the CCO changes during every TILS/sham session. Veterans' prefrontal functions will be evaluated with short-term memory tasks before and after each intervention. The prefrontal activities will also be imaged by functional near-infrared spectroscopy (fNIRS) to objectively assess the functional changes due to TILS/sham interventions.

Interventions

DEVICETILS

Continuous-wave laser of a specific wavelength (1064 nm) was administered to the participants' right forehead for 8 minutes. The laser power was 3.4 Watts.

DEVICEsham

The sham session consisted of administering the same laser to the participants' right forehead for totally 8 minutes. However, the laser power was turned to be 0 Watts.

Sponsors

University of Texas at Austin
CollaboratorOTHER
The University of Texas at Arlington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* War-zone and non-war-zone veterans * Ages 18-60 years old * Males and females * Able to read, speak, and understand English * Medical records showing prior diagnosis of PTSD (here it refers to the records prior to TILS, which will be assessed and obtained in Visit 1) * Medical records showing diagnosis of PTSD (here it refers to the CAPS-5 record prior to TILS, which will be assessed and obtained in Visit 1) * On stable doses of any psychotropic medications for at least 4 weeks

Exclusion criteria

* Significant physical disability to perform a computerized memory task * Past/current significant medical/neurological/mental health disorders known to affect cognitive functioning (e.g., stroke, dementia, schizophrenia, AIDS) * Presence of moderate/severe TBI, defined as having: alteration of consciousness/mental state \>24 hours; posttraumatic amnesia \>1 day; loss of consciousness \>30 minutes; and/or abnormal structural neuroimaging. We will not exclude veterans with mild TBI, which is found in nearly 50% of veterans with PTSD * Alcohol abuse/dependence for the past 12- months, as determined by the Rapid Alcohol Problems Screen score \>0 * Drug abuse/dependence for the past 12- months, as determined by the Drug Abuse Screening Test-10 score \>2 * Severe depression (PHQ-9 total score \>19), significant risk of suicide (SBQ-R \>6), severe headache (PHQ-15, Item e =2), and/or severe dizziness (PHQ-15, Item g =2) * Opiate use in the month prior to study entry

Design outcomes

Primary

MeasureTime frameDescription
Cerebral CCO Changes in Response to TILS and Sham7 weeksCerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Cerebral Hemodynamic Changes in Response to TILS and Sham7 weeksCerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session

Secondary

MeasureTime frameDescription
Short-term Memory Scores8 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.
Prefrontal Activations in Short-term Memory Processing8 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

All of the nine participants were randomly assigned into the two arms.

Participants by arm

ArmCount
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.
6
One Sham, Then Six TILS Interventions
Participants first received a sham session, followed by six weekly TILS sessions.
3
Total9

Baseline characteristics

CharacteristicOne TILS, One Sham, and Then Five TILS InterventionsOne Sham, Then Six TILS InterventionsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants3 Participants9 Participants
Age, Continuous36.3 years
STANDARD_DEVIATION 12.7
36.33 years
STANDARD_DEVIATION 12.7
36.3 years
STANDARD_DEVIATION 12.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants1 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
3 Participants3 Participants6 Participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
5 Participants2 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 3
other
Total, other adverse events
0 / 60 / 3
serious
Total, serious adverse events
0 / 60 / 3

Outcome results

Primary

Cerebral CCO Changes in Response to TILS and Sham

Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.

Time frame: 7 weeks

ArmMeasureGroupValue (MEAN)Dispersion
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 2nd TILS0.03 microMolar/LStandard Deviation 0.27
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 4th TILS-0.12 microMolar/LStandard Deviation 0.57
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 1st TILS0.13 microMolar/LStandard Deviation 0.23
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 5th TILS0.08 microMolar/LStandard Deviation 0.23
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 3rd TILS0.04 microMolar/LStandard Deviation 0.26
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 6th TILS0.09 microMolar/LStandard Deviation 0.13
One TILS, One Sham, and Then Five TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to sham0.09 microMolar/LStandard Deviation 0.21
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 6th TILS1.03 microMolar/LStandard Deviation 1.78
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to sham-0.33 microMolar/LStandard Deviation 0.58
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 1st TILS0.70 microMolar/LStandard Deviation 1.22
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 2nd TILS1.44 microMolar/LStandard Deviation 2.58
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 3rd TILS2.39 microMolar/LStandard Deviation 4.18
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 4th TILS0.86 microMolar/LStandard Deviation 1.75
One Sham, Then Six TILS InterventionsCerebral CCO Changes in Response to TILS and ShamAverage CCO changes in response to 5th TILS0.47 microMolar/LStandard Deviation 1.01
Primary

Cerebral Hemodynamic Changes in Response to TILS and Sham

Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session

Time frame: 7 weeks

ArmMeasureGroupValue (MEAN)Dispersion
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 1st TILS0.08 microMolar/LStandard Deviation 0.47
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 3rd TILS0.12 microMolar/LStandard Deviation 0.21
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to sham0.40 microMolar/LStandard Deviation 0.26
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 4th TILS2.92 microMolar/LStandard Deviation 2.19
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 2nd TILS3.08 microMolar/LStandard Deviation 1.57
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 4th TILS0.21 microMolar/LStandard Deviation 0.48
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 1st TILS2.80 microMolar/LStandard Deviation 1.71
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 5th TILS2.44 microMolar/LStandard Deviation 1.23
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 2nd TILS0.37 microMolar/LStandard Deviation 0.27
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 5th TILS0.64 microMolar/LStandard Deviation 0.54
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 6th TILS2.73 microMolar/LStandard Deviation 1.6
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to sham0.28 microMolar/LStandard Deviation 1.76
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 6th TILS0.07 microMolar/LStandard Deviation 0.65
One TILS, One Sham, and Then Five TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 3rd TILS3.97 microMolar/LStandard Deviation 1.44
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 6th TILS1.31 microMolar/LStandard Deviation 3.61
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to sham-0.95 microMolar/LStandard Deviation 1.85
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to sham-1.12 microMolar/LStandard Deviation 2.56
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 1st TILS2.77 microMolar/LStandard Deviation 5.13
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 1st TILS1.66 microMolar/LStandard Deviation 2.03
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 2nd TILS3.58 microMolar/LStandard Deviation 3.97
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 2nd TILS2.52 microMolar/LStandard Deviation 3.53
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 3rd TILS2.60 microMolar/LStandard Deviation 2.43
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 3rd TILS3.37 microMolar/LStandard Deviation 5.42
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 4th TILS2.77 microMolar/LStandard Deviation 3.01
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 4th TILS1.89 microMolar/LStandard Deviation 3.51
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 5th TILS3.05 microMolar/LStandard Deviation 1.45
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage oxy-Hb change in response to 6th TILS4.93 microMolar/LStandard Deviation 4.1
One Sham, Then Six TILS InterventionsCerebral Hemodynamic Changes in Response to TILS and ShamAverage deoxy-Hb change in response to 5th TILS1.04 microMolar/LStandard Deviation 2.26
Secondary

Prefrontal Activations in Short-term Memory Processing

Anterior 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.

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, baseline1.4 microMolar/LStandard Deviation 2.2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 2nd TILS0.7 microMolar/LStandard Deviation 1.1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, sham-0.1 microMolar/LStandard Deviation 1.2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 3rd TILS-1.0 microMolar/LStandard Deviation 1.7
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, baseline0.5 microMolar/LStandard Deviation 2.2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 1st TILS0.0 microMolar/LStandard Deviation 2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 3rd TILS-3.3 microMolar/LStandard Deviation 2.2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, baseline0.7 microMolar/LStandard Deviation 1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 3rd TILS-1.1 microMolar/LStandard Deviation 1.1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 1st TILS0.0 microMolar/LStandard Deviation 0.5
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 3rd TILS-0.2 microMolar/LStandard Deviation 0.3
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 4th TILS0.1 microMolar/LStandard Deviation 0.7
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 1st TILS-2.5 microMolar/LStandard Deviation 4
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 4th TILS-1.3 microMolar/LStandard Deviation 3.4
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, sham-0.6 microMolar/LStandard Deviation 3.1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 4th TILS-0.1 microMolar/LStandard Deviation 0.6
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, baseline-0.4 microMolar/LStandard Deviation 0.4
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 5th TILS-3.2 microMolar/LStandard Deviation 2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 2nd TILS-2.6 microMolar/LStandard Deviation 0.8
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 5th TILS-0.3 microMolar/LStandard Deviation 1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 5th TILS-2.8 microMolar/LStandard Deviation 3.5
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, sham0.0 microMolar/LStandard Deviation 0.7
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 5th TILS0.2 microMolar/LStandard Deviation 1
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 4th TILS-1.6 microMolar/LStandard Deviation 2.8
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 6th TILS-2.0 microMolar/LStandard Deviation 1.2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 2nd TILS-0.1 microMolar/LStandard Deviation 0.6
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 6th TILS-0.1 microMolar/LStandard Deviation 0.9
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, sham-1.1 microMolar/LStandard Deviation 2.7
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 6th TILS0.4 microMolar/LStandard Deviation 2.9
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 2nd TILS1.0 microMolar/LStandard Deviation 2
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 6th TILS0.2 microMolar/LStandard Deviation 1.4
One TILS, One Sham, and Then Five TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 1st TILS-0.5 microMolar/LStandard Deviation 1.3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 6th TILS0.3 microMolar/LStandard Deviation 0.3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, baseline0.5 microMolar/LStandard Deviation 1.4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, baseline-0.8 microMolar/LStandard Deviation 1.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, baseline-0.5 microMolar/LStandard Deviation 2
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, baseline0.3 microMolar/LStandard Deviation 0.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, sham-2.3 microMolar/LStandard Deviation 1.7
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, sham-0.3 microMolar/LStandard Deviation 0.4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, sham-0.7 microMolar/LStandard Deviation 1.1
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, sham0.2 microMolar/LStandard Deviation 0.4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 1st TILS-1.2 microMolar/LStandard Deviation 1.3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 1st TILS0.1 microMolar/LStandard Deviation 0.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 1st TILS-1.4 microMolar/LStandard Deviation 4.4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 1st TILS0.4 microMolar/LStandard Deviation 1.1
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 5th TILS0.4 microMolar/LStandard Deviation 0.3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 2nd TILS0.8 microMolar/LStandard Deviation 3.8
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 2nd TILS-1.1 microMolar/LStandard Deviation 2.6
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 2nd TILS3.9 microMolar/LStandard Deviation 9.6
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 2nd TILS2.2 microMolar/LStandard Deviation 3.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 3rd TILS0.6 microMolar/LStandard Deviation 4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 3rd TILS0.8 microMolar/LStandard Deviation 0.2
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 3rd TILS-1.0 microMolar/LStandard Deviation 1
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 3rd TILS0.1 microMolar/LStandard Deviation 0.4
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 4th TILS-1.8 microMolar/LStandard Deviation 1.8
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 4th TILS0.1 microMolar/LStandard Deviation 0.3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 4th TILS-1.1 microMolar/LStandard Deviation 3.7
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 4th TILS-0.8 microMolar/LStandard Deviation 1
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 5th TILS0.6 microMolar/LStandard Deviation 2
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 5th TILS0.6 microMolar/LStandard Deviation 3
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB Hb, 5th TILS0.4 microMolar/LStandard Deviation 0.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF HbO2, 6th TILS-0.4 microMolar/LStandard Deviation 1.5
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDF Hb, 6th TILS0.4 microMolar/LStandard Deviation 0.7
One Sham, Then Six TILS InterventionsPrefrontal Activations in Short-term Memory ProcessingDB HbO2, 6th TILS-5.7 microMolar/LStandard Deviation 8.4
Secondary

Short-term Memory Scores

The 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.

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 1st TILS6.1 secondStandard Deviation 2.3
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 2nd TILS8.4 secondStandard Deviation 2.7
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, baseline7.1 secondStandard Deviation 2.9
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, baseline10.8 secondStandard Deviation 4.8
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, sham5.4 secondStandard Deviation 1.3
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, sham8.1 secondStandard Deviation 2.7
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 1st TILS8.4 secondStandard Deviation 2.9
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 2nd TILS5.6 secondStandard Deviation 1.4
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 3rd TILS5.2 secondStandard Deviation 1.1
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 3rd TILS7.4 secondStandard Deviation 1.7
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 4th TILS5.0 secondStandard Deviation 1
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 4th TILS6.3 secondStandard Deviation 1
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 5th TILS5.1 secondStandard Deviation 0.9
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 5th TILS6.2 secondStandard Deviation 1.2
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDF recall time, 6th TILS4.9 secondStandard Deviation 0.6
One TILS, One Sham, and Then Five TILS InterventionsShort-term Memory ScoresDB recall time, 6th TILS6.5 secondStandard Deviation 1.5
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 6th TILS7.9 secondStandard Deviation 4.6
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 1st TILS5.9 secondStandard Deviation 3.3
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 3rd TILS5.9 secondStandard Deviation 3.5
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 5th TILS5.6 secondStandard Deviation 3.4
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, baseline6.5 secondStandard Deviation 3.4
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 3rd TILS11.1 secondStandard Deviation 7.3
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, baseline9.5 secondStandard Deviation 3.7
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 6th TILS5.7 secondStandard Deviation 3.3
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, sham5.7 secondStandard Deviation 2.5
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 4th TILS6.3 secondStandard Deviation 3.1
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, sham8.6 secondStandard Deviation 3.3
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 5th TILS8.5 secondStandard Deviation 5.5
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 1st TILS9.9 secondStandard Deviation 6.9
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 4th TILS7.9 secondStandard Deviation 5
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDF recall time, 2nd TILS5.9 secondStandard Deviation 2.8
One Sham, Then Six TILS InterventionsShort-term Memory ScoresDB recall time, 2nd TILS9.2 secondStandard Deviation 5.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026