Trial Outcomes & Findings for Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder (NCT NCT05363982)

NCT ID: NCT05363982

Last Updated: 2026-01-27

Results Overview

The CGI-ASD-I is a clinician-rated measure of ASD symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-ASD-I scores of 1 or 2 at study endpoint.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2026-01-27

Participant Flow

41 participants signed consent to participate in the trial, only 30 of those participants were randomized.

Participant milestones

Measure	Sham Participants who received sham treatment	tPBM Treatment Participants who received tPBM treatment
Overall Study STARTED	15	15
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder

Baseline characteristics by cohort

Measure	Sham n=12 Participants Participants who received sham treatment	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=25 Participants	13 Participants n=25 Participants	25 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Sex: Female, Male Female	5 Participants n=25 Participants	6 Participants n=25 Participants	11 Participants n=50 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	7 Participants n=25 Participants	14 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=25 Participants	13 Participants n=25 Participants	24 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race/Ethnicity, Customized Asian; Native Hawaiian; Pacific Islander	3 Participants n=25 Participants	0 Participants n=25 Participants	3 Participants n=50 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=25 Participants	1 Participants n=25 Participants	1 Participants n=50 Participants
Race/Ethnicity, Customized White/Caucasian	7 Participants n=25 Participants	11 Participants n=25 Participants	18 Participants n=50 Participants
Race/Ethnicity, Customized Other	1 Participants n=25 Participants	1 Participants n=25 Participants	2 Participants n=50 Participants
Race/Ethnicity, Customized Unknown/Not reported	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The CGI-ASD-I is a clinician-rated measure of ASD symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-ASD-I scores of 1 or 2 at study endpoint.

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Participant Improvement in ASD Symptoms as Assessed by the Clinical Global Impression of Improvement for Autism Spectrum Disorder (CGI-ASD-I)	5 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

Treatment responders at study endpoint are defined as those who have a Clinical Global Impression of Improvement for ASD (CGI-ASD-I) score ≤2 and a 25% reduction in score from baseline to study endpoint in the Social Responsiveness Scale-Version 2 (SRS-2) total raw score.

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Treatment Responders	4 Treatment responders	2 Treatment responders

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The SRS-2 is a parent-rated scale used to identify the presence and severity of social impairment within the autism spectrum and differentiate it from that which occurs in other disorders. It consists of 65 items that rated on a scale from 1 (not true) to 4 (almost always true). The item scores are recoded by a scorer to 0 (not true) to 3 (almost always true) and combined into a total score which ranges from 0 to 195, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in SRS Total raw scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Social Responsiveness Scale-2 (SRS-2)	-25.7 score on a scale Standard Deviation 14.8	-25.3 score on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Twenty participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, were not compliant with study procedures, or did not have an informant complete the scale.

The Adult Behavior Checklist (ABCL) is an observer-rated scale that assesses maladaptive behavioral and emotional problems, social competence and substance use in adults. The item scores are combined into a total score raw score and then transformed into T-scores, ranging from <50 to 80, where a higher T-score indicates a worse outcome. T-scores are calculated with a mean of 50 (population mean) and a standard deviation of 10. This total score reflects overall psychopathology. The outcome reported reflects the change from baseline in ABCL T-scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=4 Participants Participants who received tPBM treatment	Sham n=6 Participants Participants who received sham treatment
Change From Baseline in Adult Behavior Checklist (ABCL) Total T-score	-0.2 T-score Standard Deviation 8.3	-4.3 T-score Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Six participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, were not compliant with study procedures, or were discontinued due to discomfort at treatment site.

The Adult ADHD Investigator Symptom Report Scale (AISRS) is a clinician-rated scale that assesses ADHD symptoms. It consists of 18 items that are rated on a scale from 0 (not present) to 3 (severe). The item scores are combined into a total score raw score ranging from 0 to 54, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in AISRS scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=12 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Adult ADHD Investigator Symptom Report Scale (AISRS)	-8.6 score on a scale Standard Deviation 9.6	-11.8 score on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale that assesses frequency of ADHD symptoms. It consists of 18 items that are rated on a scale from 0 to 4. The item scores are combined into a total score raw score ranging from 0 to 72, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in ASRS scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Adult ADHD Self-Report Scale (ASRS)	-5.1 score on a scale Standard Deviation 7.4	-13.3 score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The BRIEF-A is a patient-rated scale that assesses the patient's level of executive function deficits. It consists of 75 items that are rated on a scale from 1 (never) to 3 (often). The item scores are combined into a total score raw score and then transformed into T-scores, ranging from 32 to 91, where a higher T-score indicates a worse outcome. T-scores are calculated with a mean of 50 (population mean) and a standard deviation of 10. This total score is called the Global Executive Composite (GEC) scale and it reflects overall executive functioning. The outcome reported reflects the change from baseline in BRIEF-A Total T-scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Behavior Rating Inventory of Executive Function-Adult Self Report Version (BRIEF-A) Total T-score	-4.8 T-score Standard Deviation 8.9	-13.0 T-score Standard Deviation 8.8

SECONDARY outcome

Timeframe: Week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The CGI-ADHD-I is a clinician-rated measure of ADHD symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-ADHD-I scores of 1 or 2 at study endpoint.

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Improvement in ADHD Symptoms as Assessed by the Clinical Global Impression of Improvement for ADHD (CGI-ADHD-I)	6 Patients	5 Patients

SECONDARY outcome

Timeframe: Week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The CGI-Anxiety-I is a clinician-rated measure of depression symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-Anxiety-I scores of 1 or 2 at study endpoint.

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Improvement in Anxiety Symptoms as Assessed by the Clinical Global Impression of Improvement for Anxiety (CGI-Anxiety-I)	8 Patients	6 Patients

SECONDARY outcome

Timeframe: Week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The CGI-Depression-I is a clinician-rated measure of depression symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-Depression-I scores of 1 or 2 at study endpoint.

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Improvement in Depression Symptoms as Assessed by the Clinical Global Impression of Improvement for Depression (CGI-Depression-I)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Six participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, were not compliant with study procedures, or were discontinued due to discomfort at treatment site.

The Hamilton Anxiety Scale (HAM-A) is a clinician-rated scale that assesses anxiety. It consists of 14 items that are rated on a scale s absent, mild, moderate, severe, or very severe. The item scores are combined into a total score raw score ranging from 17 to 30, where a higher score indicates a worse outcome The outcome reported reflects the change from baseline in HAM-A scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=12 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Hamilton Anxiety Scale (HAM-A)	-6.0 score on a scale Standard Deviation 5.3	-4.3 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Six participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, were not compliant with study procedures, or were discontinued due to discomfort at treatment site.

The Hamilton Depression Scale (HAM-D) is a clinician-rated scale that assesses severity of depression in adults. It consists of 21 items that are rated on a scale as absent, mild/trivial, moderate or severe. The item scores are combined into a total score raw score ranging from 0 to 50, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in HAM-D scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=12 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Hamilton Depression Scale (HAM-D)	-5.8 score on a scale Standard Deviation 4.2	-4.3 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Six participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, were not compliant with study procedures, or discontinued the study due to discomfort at the treatment site.

The MGH-SEC is a clinician-rate scale that assesses change in the frequency and severity of core and associated symptoms of ASD. It consists of 37 items that are rated on a scale from 1 (superior) to 8 (severely). The item scores are combined into a total score which ranges from 37 to 296, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in MGH-SEC scale scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Measure	tPBM Treatment n=12 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Massachusetts General Hospital Social Emotional Competence Scale (MGH-SEC)	-37.6 score on a scale Standard Deviation 26.7	-17.5 score on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study medication for at least two weeks. Five participants were not included because they either withdrew consent, started a new medication, had the device break and chose not to finish, or were not compliant with study procedures.

The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a patient-rated scale that assess evaluate the degree of enjoyment and satisfaction experienced in eight areas of daily functioning. It consists of 16 items that are rated on a scale from 0 (very poor) to 4 (very good). The item scores are combined into a total score raw score ranging from 0 to 64, where a higher score indicates a better quality of life. The outcome reported reflects the change from baseline in Q-LES-Q scores and positive scores represent improvement (i.e., increase in quality of life from baseline).

Outcome measures

Measure	tPBM Treatment n=13 Participants Participants who received tPBM treatment	Sham n=12 Participants Participants who received sham treatment
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	3.4 score on a scale Standard Deviation 4.5	6.4 score on a scale Standard Deviation 9.1

Adverse Events

Sham

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

tPBM Treatment

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sham n=15 participants at risk Participants who received sham treatment	tPBM Treatment n=15 participants at risk Participants who received tPBM treatment
General disorders Anaphylactic Reaction	0.00% 0/15 • Baseline to Week 8	6.7% 1/15 • Baseline to Week 8
General disorders Chest pain (exercise induced)	0.00% 0/15 • Baseline to Week 8	6.7% 1/15 • Baseline to Week 8

Other adverse events

Measure	Sham n=15 participants at risk Participants who received sham treatment	tPBM Treatment n=15 participants at risk Participants who received tPBM treatment
General disorders Headache, migraine, retinal migraine	13.3% 2/15 • Number of events 2 • Baseline to Week 8	46.7% 7/15 • Number of events 8 • Baseline to Week 8
General disorders Local/treatment site reactions and device issues: warmth, tingling, pressure, discomfort, wrinkles	13.3% 2/15 • Number of events 2 • Baseline to Week 8	86.7% 13/15 • Number of events 15 • Baseline to Week 8
General disorders Sleep problems: disturbed sleep, increased dream recall, insomnia	26.7% 4/15 • Number of events 4 • Baseline to Week 8	13.3% 2/15 • Number of events 2 • Baseline to Week 8
Psychiatric disorders Mood symptoms: flight anxiety, anxiety attack, worsened depression	13.3% 2/15 • Number of events 2 • Baseline to Week 8	6.7% 1/15 • Number of events 1 • Baseline to Week 8
General disorders Increased forgetfulness, irritability, worsening attention	6.7% 1/15 • Number of events 1 • Baseline to Week 8	13.3% 2/15 • Number of events 2 • Baseline to Week 8
General disorders Other: back pain, dizziness, fatigue, Flu, jitteriness, menstrual cramps, allergies	26.7% 4/15 • Number of events 4 • Baseline to Week 8	53.3% 8/15 • Number of events 9 • Baseline to Week 8

Additional Information

T. Atilla Ceranoglu, MD

Massachusetts General Hospital

Phone: 617-726-7899

Email: aceranoglu@mgh.harvard.edu

Results disclosure agreements

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