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

Completed · Not applicable · Has a placebo group

Conditions studied: Cognitive Change

In brief

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

Key facts

Study ID

NCT03740152

Run by

Massachusetts General Hospital

People needed

10

Starts

2017-08-22

Expected to finish

2019-05-16

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• The subject is pregnant or lactating.
• The subject is on any psychotropic medication.
• Psychotherapy is exclusionary unless the subject has had at least 8 weeks of treatment prior to the screening visit.
• Any current psychiatric disorder (per SCID assessment)
• Substance or alcohol dependence or abuse in the past 6 months.
• History of a psychotic disorder or psychotic episode (current psychotic episode per SCID assessment).
• Bipolar affective disorder (per SCID assessment).
• 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).
• Suicidal or homicidal ideation as determined by SCID screening.
• 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.
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised Arteriovenous Malformation (AVM), implantable shunt - Hakim valve).
• 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)
• Recent history of stroke (90 days).
• Personality traits that rend the subject unsuitable for the study, based on the investigators' clinical judgment.

Where it is running

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

Full record on ClinicalTrials.gov

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