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Trial Outcomes & Findings for Photobiomodulation in Autism Spectrum Disorder (ASD) (NCT NCT03724552)

NCT ID: NCT03724552

Last Updated: 2024-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2024-07-11

Participant Flow

Participant milestones

Participant milestones
Measure
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)
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Overall Study
STARTED
0
12
Overall Study
COMPLETED
0
10
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Photobiomodulation in Autism Spectrum Disorder (ASD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
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)
n=10 Participants
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Total
n=10 Participants
Total of all reporting groups
Age, Categorical
<=18 years
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
—
10 Participants
n=7 Participants
10 Participants
n=5 Participants
Age, Categorical
>=65 years
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
—
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
—
9 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
—
10 Participants
n=7 Participants
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
—
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
—
8 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
—
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Zero participants ages 9-17 enrolled

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.

Outcome measures

Outcome measures
Measure
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)
n=10 Participants
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale.
—
-30.6 scores on a scale
Standard Deviation 17.9

PRIMARY outcome

Timeframe: 8 weeks

Population: Zero participants ages 9-17 enrolled

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).

Outcome measures

Outcome measures
Measure
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)
n=10 Participants
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Number of Participants With CGI Improvement Scores of ≤ 2 at Week 8
—
7 Participants

Adverse Events

Transcranial LED Therapy (Participants Ages 9-17)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Transcranial LED Therapy (Participants Ages 18-59)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
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)
n=10 participants at risk
Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Nervous system disorders
Insomnia
—
0/0 • 8 weeks (from baseline to end of study)
10.0%
1/10 • Number of events 2 • 8 weeks (from baseline to end of study)
Nervous system disorders
Headache
—
0/0 • 8 weeks (from baseline to end of study)
20.0%
2/10 • Number of events 5 • 8 weeks (from baseline to end of study)
General disorders
Warmth at Application Site
—
0/0 • 8 weeks (from baseline to end of study)
10.0%
1/10 • Number of events 1 • 8 weeks (from baseline to end of study)

Additional Information

T. Atilla Ceranoglu, MD

Massachusetts General Hospital

Phone: 617-726-1291

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place