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

NCT03740152 | Completed Results

• 1 other identifier: 2016P002481
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

• Change in Cerebral Blood Flow (Baseline to Week 5)

  Measured using Diffuse Correlation Spectroscopy (DCS) signal.

  5 weeks

Secondary Outcomes (2)

• Change in Accuracy on N-Back Task (Baseline to Week 5)

  5 weeks

• Number of Participants With Treatment-Emergent Adverse Events

  5 weeks

Study Arms (1)

Transcranial Light Therapy

EXPERIMENTAL

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

Interventions

Transcranial Light Therapy DEVICE

Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)

Transcranial Light Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Dr. Paolo Cassano, M.D.
• Organization: Massachusetts General Hospital

pcassano@mgh.harvard.edu

617-643-9622

Study Officials

• Paolo Cassano, M.D.

  Massachusetts General Hospital Center for Anxiety and Traumatic Stress Disorders

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant receives all three types of light: continuous, pulse, and sham. They do not know when they receive each type of light, but they do know that they will receive all three.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Psychiatry

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: November 14, 2018
• Study Start: August 22, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)