Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids (tDCS25112013)

Spanish Foundation for Neurometrics Development

Status: Completed

Conditions: ASD; Autism

Treatments: Device: tRNS with sham; Device: tRNS over fusiform temporal cortex; Device: tRNS Fronto-temporal cortex

Study type: Interventional

Funder types: Other

Identifiers

NCT02004236

Autism and tDCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups, including a placebo group

tRNS Fronto-temporal cortex

Experimental group

Description:

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

Treatment:

Device: tRNS Fronto-temporal cortex

tRNS over fusiform temporal cortex

Experimental group

Description:

This group receive 35 sessions of tRNS over fusiform temporal cortex

Treatment:

Device: tRNS over fusiform temporal cortex

tRNS with sham

Placebo Comparator group

Description:

This group receive 35 sessions with sham

Treatment:

Device: tRNS with sham