Trial Outcomes & Findings for Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy (NCT NCT03740152)

NCT ID: NCT03740152

Last Updated: 2020-11-19

Results Overview

Measured using Diffuse Correlation Spectroscopy (DCS) signal.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2020-11-19

Participant Flow

Participant milestones

Measure	Transcranial Light Therapy All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Transcranial Light Therapy n=10 Participants All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.6 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Measured using Diffuse Correlation Spectroscopy (DCS) signal.

Outcome measures

Measure	Transcranial Light Therapy n=10 Participants All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Change in Cerebral Blood Flow (Baseline to Week 5)	2.15 mm2/s Standard Deviation 1.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Transcranial Light Therapy n=10 Participants All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Change in Accuracy on N-Back Task (Baseline to Week 5)	-4.49 accuracy percentage Standard Deviation 20.84

SECONDARY outcome

Timeframe: 5 weeks

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

Outcome measures

Measure	Transcranial Light Therapy n=10 Participants All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Number of Participants With Treatment-Emergent Adverse Events	3 Participants

Adverse Events

Transcranial Light Therapy Recipients

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Transcranial Light Therapy Recipients n=10 participants at risk All participants
Psychiatric disorders Weakness/fatigue	10.0% 1/10 • Number of events 1 • Collected over course of entire treatment period and follow-up (5 weeks). There were no participants that had qualities that would make them at risk for serious adverse events or all-cause mortality in this study with this pre-studied advice.
Psychiatric disorders Trouble concentrating	10.0% 1/10 • Number of events 1 • Collected over course of entire treatment period and follow-up (5 weeks). There were no participants that had qualities that would make them at risk for serious adverse events or all-cause mortality in this study with this pre-studied advice.
Psychiatric disorders Blurred vision	10.0% 1/10 • Number of events 1 • Collected over course of entire treatment period and follow-up (5 weeks). There were no participants that had qualities that would make them at risk for serious adverse events or all-cause mortality in this study with this pre-studied advice.
Psychiatric disorders Nausea/vomiting	10.0% 1/10 • Number of events 1 • Collected over course of entire treatment period and follow-up (5 weeks). There were no participants that had qualities that would make them at risk for serious adverse events or all-cause mortality in this study with this pre-studied advice.

Additional Information

Dr. Paolo Cassano, M.D.

Massachusetts General Hospital

Phone: 617-643-9622

Email: pcassano@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place