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

Part of paid clinical trials in Newark, Delaware.

Sponsor
Christiana Care Health Services
Study ID
NCT05371912
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 25 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 15, 2022
Status verified
Nov 2025
Primary completion
Oct 31, 2023
Completion
Feb 1, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: left IPL stimulation
    half of the subjects will receive TMS on the left inferior parietal lobule.
  • Active Comparator: right IPL stimulation
    half of the subjects will receive TMS on the right inferior parietal lobule.

Primary Outcome Measure

The Effects of rTMS on Reciprocal Social Awareness [ Time Frame: at baseline and 5 weeks of rTMS ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mitra AssadiNewarkDelaware19713-

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