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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcranial Random Noise Noninvasive Brain Stimulation Applied to the Fronto-temporal Cortex Improves Verbal Fluency and Emphaty in Children With Autistic Spectrum Disorder

Conditions
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Autism, ASD

Intervention / Treatment
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* Device: tRNS Fronto-temporal cortex
* Device: tRNS over fusiform temporal cortex
* Device: tRNS with sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tRNS Fronto-temporal cortex<br>This group receive 35 sessions of tRNS over fronto-temporal cortex | Device: tRNS Fronto-temporal cortex<br>* This group receive 35 sessions of tRNS over fronto-temporal cortex<br>|
| Experimental: tRNS over fusiform temporal cortex<br>This group receive 35 sessions of tRNS over fusiform temporal cortex | Device: tRNS over fusiform temporal cortex<br>* This group receive 35 sessions of tRNS over fusiform temporal cortex<br>|
| Placebo Comparator: tRNS with sham<br>This group receive 35 sessions with sham | Device: tRNS with sham<br>* the subjects receive 35 session with sham<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | During 3 months of intensive speech therapy during tRNS sessions | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERP, tRNS, QEEG, ASD, Autism, verbal fluency, empathy, noninvasive brain stimulation, tDCS