Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids (tDCS25112013)

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

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.

Study Overview

• Status: Completed
• Conditions: Autism; ASD
• Intervention / Treatment: Device: tRNS Fronto-temporal cortex; Device: tRNS over fusiform temporal cortex; Device: tRNS with sham

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L1 0AH
      • New Remedies Ltd
  • Spain
    • Liverpool, Spain, United Kingdom, L4 5QL
      • Moises Aguilar Domingo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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 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.	During 3 months of intensive speech therapy during tRNS sessions
Theta Amplitude in T5 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.	During 3 months of intensive speech therapy during tRNS sessions
Ratio Theta/Beta After 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 tDCS intervention in ASD children between 5 and 12 years old.	During 3 months of intensive speech therapy during tDCS sessions
Theta Amplitude in T5 After tDCS	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 tDCS	ERP & Behaviour changes in ASD children after tDCS	During 3 months of intensive speech therapy during tRNS sessions
Omission Errors Before tDCS	ERP and behaviour changes in ASD children before tDCS	During 3 months of intensive speech therapy during tRNS sessions
Commission Errors Before tDCS	ERP and Behaviour changes in ASD children before tDCS	During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude Before tDCS	ERP and behaviour Changes in ASD children before tDCS	During 3 months of intensive speech therapy during tRNS sessions
Reaction Time After tDCS	ERP and behaviour Changes in ASD children after tDCS	During 3 months of intensive speech therapy during tDCS sessions
Omissions Errors After tDCS	ERP and behaviour Changes in ASD children after tDCS	During 3 months of intensive speech therapy during tDCS sessions
Commission Errors After tDCS	ERP and behaviour Changes in ASD children after tDCS	During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude After tDCS	ERP and behaviour Changes in ASD children after tDCS	During 3 months of intensive speech therapy during tDCS sessions

Collaborators and Investigators

• Sponsor: Spanish Foundation for Neurometrics Development
• Investigators: Principal Investigator: Jean Neville, MD, New Remedies Ltd

Publications and helpful links

Helpful Links

• Bigdata4brain LTD

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimated): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: tDCS; ASD; Autism; noninvasive brain stimulation; empathy; ERP; QEEG; verbal fluency
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: Autism and tDCS