Transcranial Random Noise Noninvasive Brain Stimulation Applied to the Fronto-temporal Cortex Improves Verbal Fluency and Emphaty in Children With Autistic Spectrum Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- Spanish Foundation for Neurometrics Development
- Enrollment
- 225
- Locations
- 2
- Primary Endpoint
- Verbal Fluency
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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)
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
- Ratio Theta/Beta Before tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Theta Amplitude in T5 Before tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Ratio Theta/Beta After tDCS(During 3 months of intensive speech therapy during tDCS sessions)
- Theta Amplitude in T5 After tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Reaction Time in ECPT Before tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Omission Errors Before tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Commission Errors Before tDCS(During 3 months of intensive speech therapy during tDCS sessions)
- P3b Wave Amplitude Before tDCS(During 3 months of intensive speech therapy during tRNS sessions)
- Reaction Time After tDCS(During 3 months of intensive speech therapy during tDCS sessions)
- Omissions Errors After tDCS(During 3 months of intensive speech therapy during tDCS sessions)
- Commission Errors After tDCS(During 3 months of intensive speech therapy during tDCS sessions)
- P3b Wave Amplitude After tDCS(During 3 months of intensive speech therapy during tDCS sessions)