Trial Outcomes & Findings for Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With ADHD (NCT NCT04569058)

Last Updated: 2025-12-08

Results Overview

The ADHD-SCL is a clinician-rated scale used to determine the number and severity of ADHD symptoms that a patient may be experiencing. It consists of 18 items that rated on a scale from 0 (no symptoms) to 3 (severe symptoms). The item scores are combined into a total score which ranges from 0 to 54, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in ADHD-SCL scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

Baseline to week 8

Results posted on

2025-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Participants ages 9-17 Participants ages 9-17 enrolled to receive tPBM treatment.
Overall Study STARTED	38
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seven participants were excluded from the analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Ages 9-17 n=31 Participants Participants ages 9-17 enrolled to receive tPBM treatment
Age, Categorical <=18 years	31 Participants n=37 Participants • Seven participants were excluded from the analysis
Age, Categorical Between 18 and 65 years	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Age, Categorical >=65 years	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Sex: Female, Male Female	7 Participants n=37 Participants • Seven participants were excluded from the analysis
Sex: Female, Male Male	24 Participants n=37 Participants • Seven participants were excluded from the analysis
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=37 Participants • Seven participants were excluded from the analysis
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=37 Participants • Seven participants were excluded from the analysis
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) Asian	1 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) White	24 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) More than one race	1 Participants n=37 Participants • Seven participants were excluded from the analysis
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants • Seven participants were excluded from the analysis

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study treatment for at least two weeks.

Outcome measures

Outcome measures
Measure	tPBM treatment n=31 Participants Participants who received tPBM treatment
Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL)	-8.5 change in scale score Standard Deviation 8.8

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Participants who were exposed to study treatment for at least two weeks.

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). Items are 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

Outcome measures
Measure	tPBM treatment n=31 Participants Participants who received tPBM treatment
Change From Baseline in Social Responsiveness Scale-2 (SRS-2)	-25.5 change in scale score Standard Deviation 26.4

SECONDARY outcome

Timeframe: Week 8 (study endpoint)

Population: Participants who were exposed to study treatment for at least two weeks.

The TSRQ is a patient-rated scale used to assess the safety of transcranial photobiomodulation for treatment of autistic traits in youth with ADHD. It consists of 5 items, with the first item assessing patient discomfort during the transcranial photobiomodulation on a scale of 0 (no discomfort) to 5 (extreme discomfort). The outcome reported reflects the number of patients who experienced each discomfort level at the last study visit.

Outcome measures

Outcome measures
Measure	tPBM treatment n=31 Participants Participants who received tPBM treatment
Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) Severe discomfort at study end point	0 participants
Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) Extreme discomfort at study end point	0 participants
Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) No discomfort at study end point	27 participants
Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) Mild discomfort at study end point	4 participants
Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) Moderate discomfort at study end point	0 participants

Adverse Events

Participants ages 9-17

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants ages 9-17 n=31 participants at risk Participants ages 9-17 enrolled to receive tPBM treatment
General disorders Headache/ Migraines	29.0% 9/31 • Number of events 12 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
Infections and infestations Flu/cold like symptoms: sore throat, sinusitis, post nasal drip	38.7% 12/31 • Number of events 13 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
General disorders Sleep-related: insomnia, early insomnia, nightmare, sleep talking, vivid dreams	29.0% 9/31 • Number of events 10 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
Gastrointestinal disorders Gastrointestinal: acute GE, heartburn	6.5% 2/31 • Number of events 2 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
Psychiatric disorders Mood symptoms: anhedonia, depressed symptoms, school anxiety, separation anxiety	12.9% 4/31 • Number of events 4 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
General disorders Other: fatigue, redness on cheeks, sweating, eye pain, toothache, nosebleed	22.6% 7/31 • Number of events 8 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
Immune system disorders Allergies, Itch	6.5% 2/31 • Number of events 2 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
General disorders Iritability/ distractibility	12.9% 4/31 • Number of events 4 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)
Skin and subcutaneous tissue disorders Local/treatment site reactions: warmth, discomfort, acne	35.5% 11/31 • Number of events 14 • Adverse events in all participants who started treatment (baseline through week 10 follow-up visit)

Additional Information

T. Atilla Ceranoglu, MD

Massachusetts General Hospital

Phone: 617-726-1291

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place