NCT03209882

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

Terminated NA Results posted Last updated 23 July 2021

What this trial tests

NA trial testing TILS in Post-traumatic Stress Disorder (PTSD) in 10 participants. Terminated before completion.

Timeline

1 October 2017

Primary endpoint
8 October 2019

8 October 2019

Quick facts

Lead sponsor	The University of Texas at Arlington
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	10
Start date	1 October 2017
Primary completion	8 October 2019
Estimated completion	8 October 2019
Sites	1 location across United States

Drugs / interventions tested

• TILS — full drug profile →
• sham

Conditions studied

• Post-traumatic Stress Disorder (PTSD) — all drugs for Post-traumatic Stress Disorder (PTSD) →

Sponsor

The University of Texas at Arlington

Who can join

Adults 18 to 60, any sex, with Post-traumatic Stress Disorder (PTSD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cerebral CCO Changes in Response to TILS and Sham Primary · 7 weeks

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

Average CCO changes in response to sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.09	± 0.21
One Sham, Then Six TILS Interventions	-0.33	± 0.58

Average CCO changes in response to 1st TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.13	± 0.23
One Sham, Then Six TILS Interventions	0.70	± 1.22

Average CCO changes in response to 2nd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.03	± 0.27
One Sham, Then Six TILS Interventions	1.44	± 2.58

Average CCO changes in response to 3rd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.04	± 0.26
One Sham, Then Six TILS Interventions	2.39	± 4.18

Average CCO changes in response to 4th TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	-0.12	± 0.57
One Sham, Then Six TILS Interventions	0.86	± 1.75

Average CCO changes in response to 5th TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.08	± 0.23
One Sham, Then Six TILS Interventions	0.47	± 1.01

Average CCO changes in response to 6th TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.09	± 0.13
One Sham, Then Six TILS Interventions	1.03	± 1.78

Cerebral Hemodynamic Changes in Response to TILS and Sham Primary · 7 weeks

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

Average deoxy-Hb change in response to sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.40	± 0.26
One Sham, Then Six TILS Interventions	-0.95	± 1.85

Average oxy-Hb change in response to sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.28	± 1.76
One Sham, Then Six TILS Interventions	-1.12	± 2.56

Average oxy-Hb change in response to 1st TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	2.80	± 1.71
One Sham, Then Six TILS Interventions	2.77	± 5.13

Average deoxy-Hb change in response to 1st TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.08	± 0.47
One Sham, Then Six TILS Interventions	1.66	± 2.03

Average oxy-Hb change in response to 2nd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	3.08	± 1.57
One Sham, Then Six TILS Interventions	3.58	± 3.97

Average deoxy-Hb change in response to 2nd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.37	± 0.27
One Sham, Then Six TILS Interventions	2.52	± 3.53

Average oxy-Hb change in response to 3rd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	3.97	± 1.44
One Sham, Then Six TILS Interventions	2.60	± 2.43

Average deoxy-Hb change in response to 3rd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.12	± 0.21
One Sham, Then Six TILS Interventions	3.37	± 5.42

Short-term Memory Scores Secondary · 8 weeks

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.

DF recall time, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	7.1	± 2.9
One Sham, Then Six TILS Interventions	6.5	± 3.4

DB recall time, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	10.8	± 4.8
One Sham, Then Six TILS Interventions	9.5	± 3.7

DF recall time, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	5.4	± 1.3
One Sham, Then Six TILS Interventions	5.7	± 2.5

DB recall time, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	8.1	± 2.7
One Sham, Then Six TILS Interventions	8.6	± 3.3

DF recall time, 1st TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	6.1	± 2.3
One Sham, Then Six TILS Interventions	5.9	± 3.3

DB recall time, 1st TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	8.4	± 2.9
One Sham, Then Six TILS Interventions	9.9	± 6.9

DF recall time, 2nd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	5.6	± 1.4
One Sham, Then Six TILS Interventions	5.9	± 2.8

DB recall time, 2nd TILS

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	8.4	± 2.7
One Sham, Then Six TILS Interventions	9.2	± 5.8

Prefrontal Activations in Short-term Memory Processing Secondary · 8 weeks

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.

DF HbO2, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.5	± 2.2
One Sham, Then Six TILS Interventions	0.5	± 1.4

DF Hb, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	-0.4	± 0.4
One Sham, Then Six TILS Interventions	-0.8	± 1.5

DB HbO2, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	1.4	± 2.2
One Sham, Then Six TILS Interventions	-0.5	± 2.0

DB Hb, baseline

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.7	± 1.0
One Sham, Then Six TILS Interventions	0.3	± 0.5

DF HbO2, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	-0.6	± 3.1
One Sham, Then Six TILS Interventions	-2.3	± 1.7

DF Hb, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	0.0	± 0.7
One Sham, Then Six TILS Interventions	-0.3	± 0.4

DB HbO2, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	-1.1	± 2.7
One Sham, Then Six TILS Interventions	-0.7	± 1.1

DB Hb, sham

Group	Value	95% CI
One TILS, One Sham, and Then Five TILS Interventions	-0.1	± 1.2
One Sham, Then Six TILS Interventions	0.2	± 0.4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.