AutismNCT03724552
Photobiomodulation in Autism Spectrum Disorder (ASD)
A study testing Transcranial LED Therapy (Participants ages 9-17) and Transcranial LED Therapy (Participants ages 18-59) in people with Autism and Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 59 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Transcranial LED Therapy (Participants ages 9-17) and Transcranial LED Therapy (Participants ages 18-59)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of LED Therapeutic Effect in Youth and Adults With Autism Spectrum Disorder: An Open-Label Pilot Study of a Novel Approach
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).
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Transcranial LED Therapy (Participants ages 9-17), Transcranial LED Therapy (Participants ages 18-59)
- Keywords
- photobiomodulation
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial LED Therapy (Participants ages 9-17) |
| 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. Receives: Device: Transcranial LED Therapy (Participants ages 18-59) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start13 Apr 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolga A Ceranoglu, Massachusetts General Hospital
- Investigators
- Tolga A Ceranoglu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724552
- Sponsor's protocol ID
- 2016P002826
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2018
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34941429
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of LED Therapeutic Effect in Youth and Adults With Autism Spectrum Disorder: An Open-Label Pilot Study of a Novel Approach
- ClinicalTrials.gov ID
- NCT03724552
- Acronym / sponsor ID
- 2016P002826
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial LED Therapy (Participants ages 9-17) | Experimental | Device: 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. |
| Transcranial LED Therapy (Participants ages 18-59) | Experimental | Device: 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. |
Who may qualify
- Ages
- 9 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcranial LED Therapy (Participants ages 9-17) |
| 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. | Device | Transcranial LED Therapy (Participants ages 18-59) |
Primary outcome
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale.
Time frame: Baseline to 8 weeks
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.
Number of Participants With CGI Improvement Scores of ≤ 2 at Week 8
Time frame: 8 weeks
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34941429Ceranoglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tolga A Ceranoglu, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial LED Therapy (Participants ages 9-17) and Transcranial LED Therapy (Participants ages 18-59) in people with Autism and Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale. (time frame: Baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.