Clinical trial NCT02004236: Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
ASD
Keywords: tDCS
QEEG
ERP
ASD
Autism
verbal fluency
empathy
noninvasive brain stimulation
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 225
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Verbal Fluency
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Sociability
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
Secondary outcomes:
measure: Ratio Theta/Beta Before tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Theta Amplitude in T5 Before tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Ratio Theta/Beta After tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
measure: Theta Amplitude in T5 After tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Reaction Time in ECPT Before tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Omission Errors Before tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Commission Errors Before tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
measure: P3b Wave Amplitude Before tDCS
timeFrame: During 3 months of intensive speech therapy during tRNS sessions
measure: Reaction Time After tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
measure: Omissions Errors After tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
measure: Commission Errors After tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
measure: P3b Wave Amplitude After tDCS
timeFrame: During 3 months of intensive speech therapy during tDCS sessions
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: New Remedies Ltd
state: Merseyside
city: Liverpool
country: United Kingdom
facility: Moises Aguilar Domingo
state: Spain
Study officials:
affiliation: New Remedies Ltd
name: Jean Neville, MD
role: PRINCIPAL_INVESTIGATOR
References: