N/A
N=10
Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy
Cognitive Change
Bottom Line
View on ClinicalTrials.gov: NCT03740152 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in Cerebral Blood Flow (Baseline to Week 5) — 2.15 mm2/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Light Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cerebral Blood Flow (Baseline to Week 5) |
2.15 | — |
| SECONDARY Change in Accuracy on N-Back Task (Baseline to Week 5) |
-4.49 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
3 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03740152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.