Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism ASD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tRNS Fronto-temporal cortex

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

Group Type EXPERIMENTAL

tRNS Fronto-temporal cortex

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

tRNS over fusiform temporal cortex

Intervention Type DEVICE

This group receive 35 sessions of tRNS over fusiform temporal cortex

tRNS with sham

This group receive 35 sessions with sham

Group Type PLACEBO_COMPARATOR

tRNS with sham

Intervention Type DEVICE

the subjects receive 35 session with sham

Interventions

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tRNS Fronto-temporal cortex

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

Intervention Type DEVICE

tRNS over fusiform temporal cortex

This group receive 35 sessions of tRNS over fusiform temporal cortex

Intervention Type DEVICE

tRNS with sham

the subjects receive 35 session with sham

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No