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

Autism Clinical Trial

— tRNS25112013  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004236
• Other study ID #: Autism and tRNS
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2023
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ASD
• Autism
• Autistic Disorder

Intervention

Device:
• tRNS Fronto-temporal cortex
This group receive 35 sessions of tRNS over fronto-temporal cortex
• tRNS over fusiform temporal cortex
This group receive 35 sessions of tRNS over fusiform temporal cortex
• tRNS with sham
the subjects receive 35 session with sham

Locations

Country	Name	City	State
Spain	General Elche Hospital	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Foundation for Neurometrics Development

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reaction Time in ECPT Before tRNS	ERP & Behaviour changes in ASD children after tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	Omission Errors Before tRNS	ERP and behaviour changes in ASD children before tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	Commission Errors Before tRNS	ERP and Behaviour changes in ASD children before tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	P3b Wave Amplitude Before tRNS	ERP and behaviour Changes in ASD children before tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	Reaction Time After tRNS	ERP and behaviour Changes in ASD children after tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	Ommision Errors After tRNS	ERP and behaviour Changes in ASD children after tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	Commission Errors After tRNS	ERP and behaviour Changes in ASD children after tRNS	During 3 months of intensive speech therapy during tRNS sessions
Secondary	P3b Wave Amplitude After tRNS	ERP and behaviour Changes in ASD children after tRNS	During 3 months of intensive speech therapy during tRNS sessions

External Links

•   Bigdata4brain LTD
•   General Elche Hospital