Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation

NCT05371912 | Completed Results FDA Device

• 1 other identifier: DDD 604994
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• The Effects of rTMS on Reciprocal Social Awareness

  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

  at baseline and 5 weeks of rTMS

• The Effects of rTMS on Reciprocal Rigid Patterns of Behavior

  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.

  at baseline and 5 weeks of rTMS

Secondary Outcomes (3)

• The Effect of rTMS on Verbal Fluency

  at baseline and 5 weeks of rTMS

• The Effects of rTMS on Executive Function Using Flanker Task

  at baseline and 5 weeks of rTMS

• The Effects of rTMS on Executive Function

  at baseline and 5 weeks of rTMS

Study Arms (2)

left IPL stimulation

ACTIVE COMPARATOR

half of the subjects will receive TMS on the left inferior parietal lobule.

Device: Trans Cranial Magnetic Stimulation

right IPL stimulation

ACTIVE COMPARATOR

half of the subjects will receive TMS on the right inferior parietal lobule.

Device: Trans Cranial Magnetic Stimulation

Interventions

Trans Cranial Magnetic Stimulation DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neurostimulation technique that alters cortical excitability by repeated induction of electromagnetic activity. FDA approved for depression, rTMS is a promising tool in the field of neuropsychiatry with an excellent safety profile.

left IPL stimulation; right IPL stimulation

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Dupont Applied Biosciences: collaborator

Study Sites (1)

Mitra Assadi

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Although we were budgeted for 20 patients, we only recruited 16 patients and 5 dropped out and did not complete behavioral measures. Fortunately, all 16 subjects completed the 10 sessions of TMS and there were no adverse effects. One of the impediments was persuading families to attend 10 sessions of TMS as well as the neuropsychic assessments.

Results Point of Contact

• Title: Mitra Assadi, MD
• Organization: Christiana Care

mitra.assadi@christianacare.org

3026233017

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The TMS coil will be placed on the scalp at a 90 degree angle and will be turned on to create the perception of delivering the stimulation to the brain.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: The patients will be randomized at the time of recruitment to either receiving left or right IPL stimulation. A shamming technique will be applied to the opposite hemisphere. Both the patient and the neuropsychologist obtaining and interpreting the outcome measures will be blinded regarding the hemispheric side of rTMS intervention. Only the clinician delivering the rTMS treatment will have a knowledge about the treatment targeting.

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 12, 2022
• Study Start: March 15, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 1, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)