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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Device: Transcranial Light Therapy

Detailed Description

During study visits a clinician applies transcranial light therapy to both sides of a participant's forehead for about 30 minutes. The study involves, 1 screening visit which may last up to 3 hours, 3 transcranial light therapy treatment visits, and 1 posttreatment visit (5 total visits to the Massachusetts General Hospital).

All eligible participants will have 1 visit with continuous light, 1 visit with pulsed light, and 1 visit with sham light. Cerebral blood flow will be measured before and after each light session using DCS-spectroscopy. During sham transcranial light therapy visits, the transcranial light therapy device will not produce near infrared waves (e.g., light energy that cannot penetrate the skin and cranium). The participant will not know which treatment is received at each visit.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects age at screening will be between 18 and 70 years old (inclusive).
2. Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
3. Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
4. The subject is willing to participate in this study for at least 5 weeks.

Exclusion Criteria:

1. The subject is pregnant or lactating.
2. The subject is on any psychotropic medication.
3. Psychotherapy is exclusionary unless the subject has had at least 8 weeks of treatment prior to the screening visit.
4. Any current psychiatric disorder (per SCID assessment)
5. Substance or alcohol dependence or abuse in the past 6 months.
6. History of a psychotic disorder or psychotic episode (current psychotic episode per SCID assessment).
7. Bipolar affective disorder (per SCID assessment).
8. Unstable medical or neurological illness, defined as any illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension).
9. Suicidal or homicidal ideation as determined by SCID screening.
10. The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be in proximity to any of the procedure sites.
11. The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised Arteriovenous Malformation (AVM), implantable shunt - Hakim valve).
12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudyne (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)
13. Recent history of stroke (90 days).
14. Personality traits that rend the subject unsuitable for the study, based on the investigators' clinical judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Light Therapy; All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT.	Device: Transcranial Light Therapy; Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cerebral Blood Flow (Baseline to Week 5)	Measured using Diffuse Correlation Spectroscopy (DCS) signal.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Accuracy on N-Back Task (Baseline to Week 5)	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.	5 weeks
Number of Participants With Treatment-Emergent Adverse Events	The safety endpoints will evaluate any reported adverse events within one week from each sessions of TLT.	5 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Paolo Cassano, M.D., Massachusetts General Hospital Center for Anxiety and Traumatic Stress Disorders

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016P002481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No