Transcranial Random Noise Stimulation (tRNS) Over Fronto-temporal Cortex Improves Verbal Fluency and Empathy in Autism Children
- Conditions
- AutismASD
- 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
- 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.
- 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
- Primary Outcome Measures
Name Time Method 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)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)
- Secondary Outcome Measures
Name Time Method Reaction Time in ECPT Before tDCS During 3 months of intensive speech therapy during tRNS sessions ERP \& Behaviour changes in ASD children after tDCS
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
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
Trial Locations
- Locations (2)
New Remedies Ltd
🇬🇧Liverpool, Merseyside, United Kingdom
Moises Aguilar Domingo
🇬🇧Liverpool, Spain, United Kingdom
New Remedies Ltd🇬🇧Liverpool, Merseyside, United Kingdom