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Photobiomodulation in Autism Spectrum Disorder (ASD)

Evaluation of LED Therapeutic Effect in Youth and Adults With Autism Spectrum Disorder: An Open-Label Pilot Study of a Novel Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03724552
Enrollment
12
Registered
2018-10-30
Start date
2017-04-13
Completion date
2019-11-25
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder

Keywords

photobiomodulation

Brief summary

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).

Interventions

DEVICETranscranial 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.

DEVICETranscranial 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

Subjects may be included in the study only if they meet all of the following criteria: * Male or female participants between 9 and 59 years of age (inclusive) * Fulfills DSM-5 diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview. * Participants with at least moderately severity of ASD symptoms as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4 * Participants must understand the nature of the study. If the participant is under the age of 18, the participant's parent/guardian must sign an IRB-approved informed consent form before initiation of any study procedures. Participants ages 18-59 must sign an IRB-approved informed consent form before the initiation of any study procedures. * Participants must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Participant experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. * Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active. * The subject is willing to participate in this study. Subjects will be excluded from the study for any of the following reasons: * Impaired intellectual capacity (clinically determined) * Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills) * Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days). * Subjects currently (within past 30 days) experiencing significant symptoms of major psychiatric disorders as clinically determined. * Subjects with an unstable medical condition (that requires clinical attention). * Active suicidal or homicidal ideation, as determined by clinical screening. * The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). * The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). * Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (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) * Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment. * Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.

Design outcomes

Primary

MeasureTime frameDescription
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale.Baseline to 8 weeksChange 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.
Number of Participants With CGI Improvement Scores of ≤ 2 at Week 88 weeksThe 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
0
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.
10
Total10

Baseline characteristics

CharacteristicTranscranial LED Therapy (Participants Ages 18-59)Total
Age, Categorical
<=18 years
0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants8 Participants
Sex: Female, Male
Female
1 Participants1 Participants
Sex: Female, Male
Male
9 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 10
other
Total, other adverse events
0 / 04 / 10
serious
Total, serious adverse events
0 / 00 / 10

Outcome results

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.

Time frame: Baseline to 8 weeks

Population: Zero participants ages 9-17 enrolled

ArmMeasureValue (MEAN)Dispersion
Transcranial LED Therapy (Participants Ages 18-59)Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale.-30.6 scores on a scaleStandard Deviation 17.9
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).

Time frame: 8 weeks

Population: Zero participants ages 9-17 enrolled

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transcranial LED Therapy (Participants Ages 18-59)Number of Participants With CGI Improvement Scores of ≤ 2 at Week 87 Participants

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026