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Completed

NCT Number: NCT02004236

Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids

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.

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Key information

Conditions

Autism ASD Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Remedies Ltd, Liverpool, Merseyside, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tRNS Fronto-temporal cortex

Device

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

tRNS over fusiform temporal cortex

Device

This group receive 35 sessions of tRNS over fusiform temporal cortex

tRNS with sham

Device

the subjects receive 35 session with sham

Primary outcomes

  1. Verbal Fluency

    Time frame: 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)

  2. Sociability

    Time frame: 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 outcomes

  1. Ratio Theta/Beta Before tDCS

    Time frame: 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.

  2. Theta Amplitude in T5 Before tDCS

    Time frame: 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.

  3. Ratio Theta/Beta After tDCS

    Time frame: 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.

  4. Theta Amplitude in T5 After tDCS

    Time frame: 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

  5. Reaction Time in ECPT Before tDCS

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

    ERP & Behaviour changes in ASD children after tDCS

  6. Omission Errors Before tDCS

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

    ERP and behaviour changes in ASD children before tDCS

  7. Commission Errors Before tDCS

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

    ERP and Behaviour changes in ASD children before tDCS

  8. P3b Wave Amplitude Before tDCS

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

    ERP and behaviour Changes in ASD children before tDCS

  9. Reaction Time After tDCS

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

    ERP and behaviour Changes in ASD children after tDCS

  10. Omissions Errors After tDCS

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

    ERP and behaviour Changes in ASD children after tDCS

  11. Commission Errors After tDCS

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

    ERP and behaviour Changes in ASD children after tDCS

  12. P3b Wave Amplitude After tDCS

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

    ERP and behaviour Changes in ASD children after tDCS

Sponsors and collaborators

Lead sponsor

Spanish Foundation for Neurometrics Development

Other

Registry information

Official study title

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

Acronym: tDCS25112013

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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