N/A
N=16
Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05371912 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: The Effects of rTMS on Reciprocal Social Awareness — 68; 79.667; 64.2; 74 total raw score (higher=worse)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trans Cranial Magnetic Stimulation (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Christiana Care Health Services
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effects of rTMS on Reciprocal Social Awareness |
68; 79.667; 64.2; 74 | — |
| PRIMARY The Effects of rTMS on Reciprocal Rigid Patterns of Behavior |
75.8; 86.667; 75.4; 81.333 | — |
| SECONDARY The Effect of rTMS on Verbal Fluency |
5.8; 8.5; 5.6; 9 | — |
| SECONDARY The Effects of rTMS on Executive Function Using Flanker Task |
66.8; 86; 71.4; 83.833 | — |
| SECONDARY The Effects of rTMS on Executive Function |
77.4; 76.8; 78.6; 80.2 | — |
Summary
Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal social and communicative milestones, as well as restrictive and/or repetitive patterns of behavior which lead to significant functional challenges impacting individuals throughout their lifespan. There are major shortcomings in the existing pharmacological interventions; they are of limited efficacy, target a subset of problematic behaviors, and fail to improve social cognition. To overcome these limitations and improve outcomes, the investigators study the use of neurostimulation to mitigate the social and cognitive manifestations of ASD.
Eligibility Criteria
Inclusion criteria
- Fulfilling the Diagnostic and Statistical Manual for Mental Disorders 5th edition (DSM-V) criteria for ASD and confirmed by Gilliam Asperger Disorder Scale (GADS)
- The patient exhibiting adequate understanding and cooperation for the procedure
Exclusion criteria
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Children with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT05371912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.