NCT03740152: NIR-Flow

Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy

Completed NA Results posted Last updated 19 November 2020

What this trial tests

NA trial testing Transcranial Light Therapy in Cognitive Change in 10 participants. Completed in 16 May 2019.

Timeline

22 August 2017

Primary endpoint
16 May 2019

16 May 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	22 August 2017
Primary completion	16 May 2019
Estimated completion	16 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Transcranial Light Therapy

Conditions studied

• Cognitive Change — all drugs for Cognitive Change →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 70, any sex, with Cognitive Change. 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.

Change in Cerebral Blood Flow (Baseline to Week 5) Primary · 5 weeks

Measured using Diffuse Correlation Spectroscopy (DCS) signal.

Group	Value	95% CI
Transcranial Light Therapy	2.15	± 1.76

Change in Accuracy on N-Back Task (Baseline to Week 5) Secondary · 5 weeks

The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and they must decide if the current stimulus is the same as the one presented 2 trials ago. Accuracy was measured as a percentage of correct to incorrect trials.

Group	Value	95% CI
Transcranial Light Therapy	-4.49	± 20.84

Number of Participants With Treatment-Emergent Adverse Events Secondary · 5 weeks

The safety endpoints will evaluate any reported adverse events within one week from each sessions of TLT.

Group	Value	95% CI
Transcranial Light Therapy	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Collected over course of entire treatment period and follow-up (5 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Transcranial Light Therapy Recipients

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (4 terms — click to expand)

Reaction	System	Transcranial Light Therapy…
Weakness/fatigue	Psychiatric disorders	—
Trouble concentrating	Psychiatric disorders	—
Blurred vision	Psychiatric disorders	—
Nausea/vomiting	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT03740152 adverse events section.

Sponsor's own description

Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism. The purpose of the study is:

To asses the change in cerebral blood flow induced by the Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects.

To correlate with cognitive performance the change in cerebral blood flow induced by the Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects.

To correlate with skin pigmentation the change in cerebral blood flow induced by the Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects.

To assess the safety and tolerability of the Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.