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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Light Therapy | Device | Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral Blood Flow (Baseline to Week 5) | Measured using Diffuse Correlation Spectroscopy (DCS) signal. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Accuracy on N-Back Task (Baseline to Week 5) | The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and they must decide if the current stimulus is the same as the one presented 2 trials ago. Accuracy was measured as a percentage of correct to incorrect trials. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Cassano, M.D. | Massachusetts General Hospital Center for Anxiety and Traumatic Stress Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Light Therapy | All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Light Therapy | All subjects will be administered 1 week of continuous TLT, 1 week of pulsed TLT, and 1 week of sham TLT. Transcranial Light Therapy: Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cerebral Blood Flow (Baseline to Week 5) | Measured using Diffuse Correlation Spectroscopy (DCS) signal. | Posted | Mean | Standard Deviation | mm2/s | 5 weeks |
|
|
Collected over course of entire treatment period and follow-up (5 weeks).
There were no participants that had qualities that would make them at risk for serious adverse events or all-cause mortality in this study with this pre-studied advice.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Light Therapy Recipients | All participants | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness/fatigue | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paolo Cassano, M.D. | Massachusetts General Hospital | 617-643-9622 | pcassano@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2017 | Jan 30, 2020 | Prot_SAP_000.pdf |
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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.
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| Number of Participants With Treatment-Emergent Adverse Events |
The safety endpoints will evaluate any reported adverse events within one week from each sessions of TLT. |
| 5 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Accuracy on N-Back Task (Baseline to Week 5) | The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and they must decide if the current stimulus is the same as the one presented 2 trials ago. Accuracy was measured as a percentage of correct to incorrect trials. | Posted | Mean | Standard Deviation | accuracy percentage | 5 weeks |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | The safety endpoints will evaluate any reported adverse events within one week from each sessions of TLT. | Posted | Count of Participants | Participants | 5 weeks |
|
|
|
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| Trouble concentrating | Psychiatric disorders | Systematic Assessment |
|
| Blurred vision | Psychiatric disorders | Systematic Assessment |
|
| Nausea/vomiting | Psychiatric disorders | Systematic Assessment |
|
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