Trial Outcomes & Findings for Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation (NCT NCT05371912)

NCT ID: NCT05371912

Last Updated: 2025-11-26

Results Overview

Social Responsiveness Scale, Second Edition (SRS-2), Parent/Caregiver form; 65 items scored 0-3; total raw score range 0-195. Higher scores = greater social impairment. This study reports raw totals (not T-scores). Instrument: SRS-2

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

at baseline and 5 weeks of rTMS

Results posted on

2025-11-26

Participant Flow

Participants were recruited from outpatient clinics and community referrals. Eligible participants were randomized 1:1 to left-IPL or right-IPL rTMS.

All patients met the diagnostic criteria for autism spectrum disorder. We excluded all patients with history of seizures or metallic devices in the hedonic area.

Participant milestones

Participant milestones
Measure	Left IPL Stimulation half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation half of the subjects will receive TMS on the right inferior parietal lobule.
Overall Study STARTED	8	8
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Left IPL Stimulation half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation half of the subjects will receive TMS on the right inferior parietal lobule.
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

5 drop outs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Left IPL Stimulation n=8 Participants 8 subjects received TMS on the left inferior parietal lobule(IPL). The average age was 13.3 years. Gender: The participants were all male Race: black, white and Asian	Right IPL Stimulation n=8 Participants 8 subjects received TMS on the right inferior parietal lobule(IPL). The average age was 13.3 years. Gender: 7 male and 1 female Race: black, white and Asian	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=8 Participants	7 Participants n=8 Participants	13 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Sex: Female, Male Female	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=16 Participants
Sex: Female, Male Male	8 Participants n=8 Participants	7 Participants n=8 Participants	15 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Asian	2 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=16 Participants
Race (NIH/OMB) White	5 Participants n=8 Participants	5 Participants n=8 Participants	10 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Social Awareness	68 total raw score (0-195; higher = worse) STANDARD_DEVIATION 9.823 • n=5 Participants • 5 drop outs	79.667 total raw score (0-195; higher = worse) STANDARD_DEVIATION 14.624 • n=6 Participants • 5 drop outs	74.364 total raw score (0-195; higher = worse) STANDARD_DEVIATION 13.515 • n=11 Participants • 5 drop outs
reciprocal rigid patterns of behavior	75.8 total raw score (0-129; higher = worse) STANDARD_DEVIATION 11.212 • n=5 Participants • 5 drop outs	86.667 total raw score (0-129; higher = worse) STANDARD_DEVIATION 14.334 • n=6 Participants • 5 drop outs	81.727 total raw score (0-129; higher = worse) STANDARD_DEVIATION 13.609 • n=11 Participants • 5 drop outs
verbal fluency	5.8 scaled score ( higher = better) STANDARD_DEVIATION 3.384 • n=5 Participants • 5 drop outs	8.5 scaled score ( higher = better) STANDARD_DEVIATION 7.778 • n=6 Participants • 5 drop outs	6.571 scaled score ( higher = better) STANDARD_DEVIATION 4.650 • n=11 Participants • 5 drop outs
Executive function	66.8 standard score (higher =better) STANDARD_DEVIATION 14.025 • n=5 Participants • 5 drop outs	86 standard score (higher =better) STANDARD_DEVIATION 22.996 • n=6 Participants • 5 drop outs	77.273 standard score (higher =better) STANDARD_DEVIATION 21.062 • n=11 Participants • 5 drop outs
Executive Function	77.4 standard score ( higher=better) STANDARD_DEVIATION 23.416 • n=5 Participants • 5 drop outs	76.8 standard score ( higher=better) STANDARD_DEVIATION 23.784 • n=6 Participants • 5 drop outs	77.1 standard score ( higher=better) STANDARD_DEVIATION 22.253 • n=11 Participants • 5 drop outs

PRIMARY outcome

Timeframe: at baseline and 5 weeks of rTMS

Population: Subjects were randomized to receive right or left IPL stimulation.

Social Responsiveness Scale, Second Edition (SRS-2), Parent/Caregiver form; 65 items scored 0-3; total raw score range 0-195. Higher scores = greater social impairment. This study reports raw totals (not T-scores). Instrument: SRS-2

Outcome measures

Outcome measures
Measure	Left IPL Stimulation n=5 Participants half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation n=6 Participants half of the subjects will receive TMS on the right inferior parietal lobule.
The Effects of rTMS on Reciprocal Social Awareness Baseline	68 total raw score (higher=worse) Standard Deviation 9.823	79.667 total raw score (higher=worse) Standard Deviation 14.624
The Effects of rTMS on Reciprocal Social Awareness Week 5	64.2 total raw score (higher=worse) Standard Deviation 5.310	74 total raw score (higher=worse) Standard Deviation 16.505

PRIMARY outcome

Timeframe: at baseline and 5 weeks of rTMS

Population: Subjects were randomized to receive right or left IPL stimulation.

Repetitive Behavior Scale-Revised (RBS-R); 43 items scored 0-3; total raw score range 0-129. Higher scores = more severe restricted/repetitive behaviors. We report total raw scores.

Outcome measures

Outcome measures
Measure	Left IPL Stimulation n=5 Participants half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation n=6 Participants half of the subjects will receive TMS on the right inferior parietal lobule.
The Effects of rTMS on Reciprocal Rigid Patterns of Behavior Week 5	75.4 total raw score (0-129; higher = worse) Standard Deviation 12.260	81.333 total raw score (0-129; higher = worse) Standard Deviation 12.879
The Effects of rTMS on Reciprocal Rigid Patterns of Behavior Baseline	75.8 total raw score (0-129; higher = worse) Standard Deviation 11.212	86.667 total raw score (0-129; higher = worse) Standard Deviation 14.334

SECONDARY outcome

Timeframe: at baseline and 5 weeks of rTMS

Population: Subjects were randomized to receive right or left IPL stimulation.

Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency; scores converted to age-normed scaled scores (mean 10, SD 3). Higher scores = better verbal fluency/executive function. We report the Total Correct scaled score per the manual.

Outcome measures

Outcome measures
Measure	Left IPL Stimulation n=5 Participants half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation n=6 Participants half of the subjects will receive TMS on the right inferior parietal lobule.
The Effect of rTMS on Verbal Fluency Week 5	5.6 scaled score (higher = better) Standard Deviation 2.793	9 scaled score (higher = better) Standard Deviation 9.899
The Effect of rTMS on Verbal Fluency Baseline	5.8 scaled score (higher = better) Standard Deviation 3.834	8.5 scaled score (higher = better) Standard Deviation 7.778

SECONDARY outcome

Timeframe: at baseline and 5 weeks of rTMS

Population: Subjects were randomized to receive right or left IPL stimulation.

NIH Toolbox Flanker Inhibitory Control and Attention; Age-Adjusted Standard Scores (mean 100, SD 15) reported. Higher scores = better inhibitory control/attention.

Outcome measures

Outcome measures
Measure	Left IPL Stimulation n=5 Participants half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation n=6 Participants half of the subjects will receive TMS on the right inferior parietal lobule.
The Effects of rTMS on Executive Function Using Flanker Task Baseline	66.8 standard score (higher =better) Standard Deviation 14.025	86 standard score (higher =better) Standard Deviation 22.996
The Effects of rTMS on Executive Function Using Flanker Task Week 5	71.4 standard score (higher =better) Standard Deviation 16.742	83.833 standard score (higher =better) Standard Deviation 24.555

SECONDARY outcome

Timeframe: at baseline and 5 weeks of rTMS

Population: Subjects were randomized to receive right or left IPL stimulation.

NIH Toolbox Dimensional Change Card Sort (DCCS); Age-Adjusted Standard Scores (mean 100, SD 15) reported. Higher scores = better cognitive flexibility.

Outcome measures

Outcome measures
Measure	Left IPL Stimulation n=5 Participants half of the subjects will receive TMS on the left inferior parietal lobule.	Right IPL Stimulation n=6 Participants half of the subjects will receive TMS on the right inferior parietal lobule.
The Effects of rTMS on Executive Function Baseline	77.4 standard score (higher =better) Standard Deviation 23.416	76.8 standard score (higher =better) Standard Deviation 23.784
The Effects of rTMS on Executive Function Week 5	78.6 standard score (higher =better) Standard Deviation 17.544	80.2 standard score (higher =better) Standard Deviation 23.721

Adverse Events

Left IPL Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Right IPL Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mitra Assadi, MD

Christiana Care

Phone: 3026233017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place