Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740152
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital

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


Condition or disease Intervention/treatment Phase
Cognitive Change Device: Transcranial Light Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : May 16, 2019
Estimated Study Completion Date : August 22, 2019

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)




Primary Outcome Measures :
  1. Correlations of Diffuse Correlation Spectroscopy (DCS) and Transcranial Light Therapy to measure cerebral blood flow [ Time Frame: 5 weeks ]
    The effect of TLT on cerebral blood flow will be assessed before and after each session (c-TLT, s-TLT and p-TLT) by measuring the Diffuse Correlation Spectroscopy (DCS) signal.


Secondary Outcome Measures :
  1. N-back task [ Time Frame: 5 weeks ]
    The effect of TLT on working memory will be assessed immediately after each session by n-back task.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 5 weeks ]
    The safety endpoints will evaluate any reported adverse events within one week from each sessions of TLT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740152


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Paolo Cassano, M.D. Massachusetts General Hospital Center for Anxiety and Traumatic Stress Disorders

Layout table for additonal information
Responsible Party: Paolo Cassano, Physician, Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03740152     History of Changes
Other Study ID Numbers: 2016P002481
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No