Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids

N/ACompletedNCT02004236

Spanish Foundation for Neurometrics Development225 enrolled

Overview

Interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and empathy.

Interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients receive three types of intervention tRNS: one group received 35 sessions focused on the fronto-temporal cortex, another group received 35 sessions focused on the temporal fusiform cortex and last placebo group was operated with 35 sessions tRNS. After brain noninvasive stimulation sessions, a blind analysis of the improvement in verbal fluency and empathy in patients with autism spectrum disorder is made. For each patient included a follow up period of three months will be established.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Autism ASD

Interventions

tRNS Fronto-temporal cortexDEVICE

This group receive 35 sessions of tRNS over fronto-temporal cortex

tRNS over fusiform temporal cortexDEVICE

This group receive 35 sessions of tRNS over fusiform temporal cortex

tRNS with shamDEVICE

the subjects receive 35 session with sham

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between 5 and 12 years. * Meet DSM-IV criteria for autism spectrum disorder. * Patients who have been diagnosed at least 2 years before inclusion in the study. Exclusion Criteria: * Acute visual or hearing loss. * Traumatic brain injury. * Other neurological disorders: migraine, epilepsy, tuberous sclerosis ... * Trauma at birth. * Mental retardation. * Pregnancy.

Locations (2)

New Remedies Ltd

Liverpool, Merseyside, United Kingdom

Moises Aguilar Domingo

Liverpool, Spain, United Kingdom

Outcomes

Primary Outcomes

Verbal Fluency

Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition. Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it. Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s. Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)

Time frame: During 3 months of intensive speech therapy during tRNS sessions

Sociability

Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions. CARS (Childhood Autism Rating Scale) by Shopler \& Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E. Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions. Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)

Time frame: During 3 months of intensive speech therapy during tRNS sessions

Secondary Outcomes

Ratio Theta/Beta Before tDCS

The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.

Data from ClinicalTrials.gov

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