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The purpose of this 8-week open-label study is to assess the tolerability, safety, and efficacy of Transcranial LED Therapy in patients with Autism Spectrum Disorder (ASD). The investigators propose to enroll up to 30 subjects of both genders ages 9-59 years with intact intellectual functions who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Autism Spectrum Disorder (ASD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial LED Therapy (Participants ages 9-17) | Experimental | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
|
| Transcranial LED Therapy (Participants ages 18-59) | Experimental | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial LED Therapy (Participants ages 9-17) | Device | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale. | Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity. | Baseline to 8 weeks |
| Number of Participants With CGI Improvement Scores of ≤ 2 at Week 8 | The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). | 8 weeks |
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Subjects may be included in the study only if they meet all of the following criteria:
Subjects will be excluded from the study for any of the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Tolga A Ceranoglu, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34941429 | Derived | Ceranoglu TA, Cassano P, Hoskova B, Green A, Dallenbach N, DiSalvo M, Biederman J, Joshi G. Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. Photobiomodul Photomed Laser Surg. 2022 Jan;40(1):4-12. doi: 10.1089/photob.2020.4986. Epub 2021 Dec 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial LED Therapy (Participants Ages 9-17) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
| FG001 | Transcranial LED Therapy (Participants Ages 18-59) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Zero participants ages 9-17 enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial LED Therapy (Participants Ages 9-17) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
| BG001 | Transcranial LED Therapy (Participants Ages 18-59) |
| 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 ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale. | Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity. | Zero participants ages 9-17 enrolled | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 8 weeks |
|
8 weeks (from baseline to end of study)
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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 LED Therapy (Participants Ages 9-17) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Atilla Ceranoglu, MD | Massachusetts General Hospital | 617-726-1291 | aceranoglu@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 | Jan 7, 2022 | May 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Transcranial LED Therapy (Participants ages 18-59) | Device | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
|
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Transcranial LED Therapy (Participants Ages 18-59) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. |
|
|
| Primary | Number of Participants With CGI Improvement Scores of ≤ 2 at Week 8 | The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). | Zero participants ages 9-17 enrolled | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Transcranial LED Therapy (Participants Ages 18-59) | Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain. | 0 | 10 | 0 | 10 | 4 | 10 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Warmth at Application Site | General disorders | Non-systematic Assessment |
|
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