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Photobiomodulation in Autism Spectrum Disorder (ASD)

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ClinicalTrials.gov Identifier: NCT03724552
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Tolga A Ceranoglu, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE April 13, 2017
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • Reduction in ASD Symptoms (SRS) [ Time Frame: Baseline to 8 weeks ]
    Reduction in ASD symptoms as measured by change from baseline on the clinician-rated Social Responsiveness Scale 2 (SRS-2) scale.The SRS-2 identifies social impairment associated with Autism Spectrum Disorders and quantifies its severity across the lifespan. A lower score on the SRS-2 indicates a reduction in ASD symptoms. (Minimum score=0, Maximum score= 195).
  • Reduction in ASD Symptoms (CGI) [ Time Frame: Baseline to 8 weeks ]
    Reduction in ASD symptoms as measured by change from baseline on the clinician-rated Clinical Global Impression (CGI) Improvement scales. The clinician-rated CGI can make an expert clinical global judgment about the severity of the illness (ASD) across various time points within the context of that clinical experience. A higher score CGI-improvement score indicates more improvement and therefore a reduction in ASD symptoms. (Minimum score=1, Maximum score=7).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photobiomodulation in Autism Spectrum Disorder (ASD)
Official Title  ICMJE Evaluation of LED Therapeutic Effect in Adults With Autism Spectrum Disorder: An Open-Label Pilot Study of a Novel Approach
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 18-59 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).

Participation requires treatment sessions at Massachusetts General Hospital (MGH) twice weekly for eight weeks, totaling 16 visits. Each session lasts approximately 45 minutes. During the treatment session, the subject will lie down comfortably on an exam bed. Subjects will also be asked to complete a series of self-report questionnaires related to their symptoms and quality of life.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autism Spectrum Disorder
Intervention  ICMJE Device: Transcranial LED Therapy
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm) is applied to forebrain.
Study Arms  ICMJE Experimental: Transcranial LED Therapy
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm) is applied to forebrain.
Intervention: Device: Transcranial LED Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants between 18 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 Autism Spectrum Disorder (ASD) symptoms as demonstrated by Social Responsiveness Scale 2 (SRS-2) raw score ≥ 85 and Clinical Global Impression (CGI-ASD) severity score ≥ 4
  • Participants must understand the nature of the study. Participants must sign an IRB- approved informed consent form before 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chloe Hutt Vater, BA 617-724-7301 chuttvater@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03724552
Other Study ID Numbers  ICMJE 2016P002826
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tolga A Ceranoglu, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tolga A Ceranoglu, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP