Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids

NCT02004236 | Completed Results DMC

• 1 other identifier: Autism and tDCS
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism; ASD

Keywords

tDCS; QEEG; ERP; ASD; Autism; verbal fluency; empathy; noninvasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Study Arms (3)

tRNS Fronto-temporal cortex

EXPERIMENTAL

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

Device: tRNS Fronto-temporal cortex

tRNS over fusiform temporal cortex

EXPERIMENTAL

This group receive 35 sessions of tRNS over fusiform temporal cortex

Device: tRNS over fusiform temporal cortex

tRNS with sham

PLACEBO COMPARATOR

This group receive 35 sessions with sham

Device: tRNS with sham

Interventions

tRNS Fronto-temporal cortex DEVICE

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

tRNS Fronto-temporal cortex

tRNS over fusiform temporal cortex DEVICE

This group receive 35 sessions of tRNS over fusiform temporal cortex

tRNS over fusiform temporal cortex

tRNS with sham DEVICE

the subjects receive 35 session with sham

tRNS with sham

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 5 and 12 years.
• Meet DSM-IV criteria for autism spectrum disorder.

You may not qualify if:

• Acute visual or hearing loss.
• Traumatic brain injury.
• Other neurological disorders: migraine, epilepsy, tuberous sclerosis ...
• Trauma at birth.
• Mental retardation.
• Pregnancy.

Sponsors & Collaborators

• Spanish Foundation for Neurometrics Development: lead

Study Sites (2)

New Remedies Ltd

Liverpool, Merseyside, L1 0AH, United Kingdom

Location

Moises Aguilar Domingo

Liverpool, Spain, L4 5QL, United Kingdom

Location

Related Links

• Bigdata4brain LTD

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Moises Domingo president of Brainmech Foundation
• Organization: BrainMech Foundation

moises@bigdata4brain.co.uk

+441615312645

Study Officials

• Jean Neville, MD

  New Remedies Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 19, 2024
• Results First Posted: October 16, 2014

Record last verified: 2024-05

Locations

GB (2)