Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy (NIR-Flow)
|ClinicalTrials.gov Identifier: NCT03740152|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
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|
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 (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.|
|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|
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)
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740152
|United States, Massachusetts|
|Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Paolo Cassano, M.D.||Massachusetts General Hospital Center for Anxiety and Traumatic Stress Disorders|