Transcranial Random Noise Stimulation (tRNS) Over Fronto-temporal Cortex Improves Verbal Fluency and Empathy in Autism Children

Not Applicable

Completed

Conditions: Autism
ASD

Interventions: Device: tRNS Fronto-temporal cortex
Device: tRNS with sham
Device: tRNS over fusiform temporal cortex

Registration Number: NCT02004236

Lead Sponsor: Spanish Foundation for Neurometrics Development

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tRNS Fronto-temporal cortex	tRNS Fronto-temporal cortex	This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS with sham	tRNS with sham	This group receive 35 sessions with sham
tRNS over fusiform temporal cortex	tRNS over fusiform temporal cortex	This group receive 35 sessions of tRNS over fusiform temporal cortex

Primary Outcome Measures

Name	Time	Method
Verbal Fluency	During 3 months of intensive speech therapy during tRNS sessions	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)
Sociability	During 3 months of intensive speech therapy during tRNS sessions	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)

Secondary Outcome Measures

Name	Time	Method
Ratio Theta/Beta Before tDCS	During 3 months of intensive speech therapy during tRNS sessions	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.
Theta Amplitude in T5 Before tDCS	During 3 months of intensive speech therapy during tRNS sessions	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.
Ratio Theta/Beta After tDCS	During 3 months of intensive speech therapy during tDCS sessions	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 tDCS intervention in ASD children between 5 and 12 years old.
Theta Amplitude in T5 After tDCS	During 3 months of intensive speech therapy during tRNS sessions	Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old
Reaction Time in ECPT Before tDCS	During 3 months of intensive speech therapy during tRNS sessions	ERP \& Behaviour changes in ASD children after tDCS
Omission Errors Before tDCS	During 3 months of intensive speech therapy during tRNS sessions	ERP and behaviour changes in ASD children before tDCS
Commission Errors Before tDCS	During 3 months of intensive speech therapy during tDCS sessions	ERP and Behaviour changes in ASD children before tDCS
P3b Wave Amplitude Before tDCS	During 3 months of intensive speech therapy during tRNS sessions	ERP and behaviour Changes in ASD children before tDCS
Reaction Time After tDCS	During 3 months of intensive speech therapy during tDCS sessions	ERP and behaviour Changes in ASD children after tDCS
Omissions Errors After tDCS	During 3 months of intensive speech therapy during tDCS sessions	ERP and behaviour Changes in ASD children after tDCS
Commission Errors After tDCS	During 3 months of intensive speech therapy during tDCS sessions	ERP and behaviour Changes in ASD children after tDCS
P3b Wave Amplitude After tDCS	During 3 months of intensive speech therapy during tDCS sessions	ERP and behaviour Changes in ASD children after tDCS