Trial results for a study investigating the enhancement of behavioral and cognitive outcomes in Autism Spectrum Disorder via neurostimulation were posted on ClinicalTrials.gov on 2025-11-26, with 16 participants enrolled.
Background
Autism spectrum disorder (ASD) is characterized by limitations in reciprocal social and communicative milestones, alongside restrictive and/or repetitive patterns of behavior, leading to significant functional challenges throughout an individual's lifespan. Existing pharmacological interventions have major shortcomings, including limited efficacy, targeting only a subset of problematic behaviors, and failing to improve social cognition. This study aimed to explore the use of neurostimulation to mitigate these challenges and improve outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 16 participants with Autism Spectrum Disorder. The trial investigated the use of neurostimulation, specifically repetitive Transcranial Magnetic Stimulation (rTMS), to enhance behavioral and cognitive outcomes. Participants received either Left IPL Stimulation or Right IPL Stimulation.
Key results
The trial reported several key measurements related to the effects of rTMS:
- The Effects of rTMS on Reciprocal Social Awareness (total raw score; higher=worse):
- For Left IPL Stimulation:
- Mean score of 68 (Standard Deviation 9.823).
- Mean score of 64.2 (Standard Deviation 5.310).
- For Right IPL Stimulation:
- Mean score of 79.667 (Standard Deviation 14.624).
- Mean score of 74 (Standard Deviation 16.505).
- For Left IPL Stimulation:
- The Effects of rTMS on Reciprocal Rigid Patterns of Behavior (total raw score 0-129; higher = worse):
- For Left IPL Stimulation:
- Mean score of 75.8 (Standard Deviation 11.212).
- Mean score of 75.4 (Standard Deviation 12.260).
- For Right IPL Stimulation:
- Mean score of 86.667 (Standard Deviation 14.334).
- Mean score of 81.333 (Standard Deviation 12.879).
- For Left IPL Stimulation:
- The Effect of rTMS on Verbal Fluency (scaled score; higher = better):
- For Left IPL Stimulation:
- Mean score of 5.8 (Standard Deviation 3.834).
- Mean score of 5.6 (Standard Deviation 2.793).
- For Right IPL Stimulation:
- Mean score of 8.5 (Standard Deviation 7.778).
- Mean score of 9 (Standard Deviation 9.899).
- For Left IPL Stimulation:
What this means
The posted results provide specific mean scores and standard deviations for various behavioral and cognitive outcomes in a small cohort of participants with Autism Spectrum Disorder who received rTMS. The data differentiates between left and right IPL stimulation, offering descriptive measurements for reciprocal social awareness, rigid patterns of behavior, and verbal fluency. However, without comparative analyses or statistical significance, these results primarily serve as preliminary observations, contributing to the understanding of neurostimulation's potential impact in ASD and guiding future research.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05371912, titled "Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation", were posted on 2025-11-26 on clinicaltrials.gov.