Trial record 12 of 15 for:    Open Studies | "Noise"

tRNS Over Fronto-temporal Cortex Improves Verbal Fluency and Empathy in Autism Children (tRNS25112013)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Spanish Foundation for Neurometrics Development
Sponsor:
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT02004236
First received: November 25, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Autism
ASD
Device: tRNS Fronto-temporal cortex
Device: tRNS over fusiform temporal cortex
Device: tRNS with sham
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spanish Foundation for Neurometrics Development:

Primary Outcome Measures:
  • Verbal fluency [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    improve in verbal fluency in autism spectrum disorder children between 5 and 12 years

  • Sociability [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions


Secondary Outcome Measures:
  • QEEG changes in children with ASD [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    Evaluate QEEG (brainwave changes in frequecy bands and amplitude) after tRNS intervention in ASD children between 5 and 12 years old

  • ERP changes in ASD children after tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    Measure changes in ERP waves after tRNS intervention during 3 months in ASD children between 5 and 12 years old


Estimated Enrollment: 225
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tRNS Fronto-temporal cortex
This group receive 35 sessions of tRNS over fronto-temporal cortex
Device: tRNS Fronto-temporal cortex
This group receive 35 sessions of tRNS over fronto-temporal cortex
Experimental: tRNS over fusiform temporal cortex
This group receive 35 sessions of tRNS over fusiform temporal cortex
Device: tRNS over fusiform temporal cortex
This group receive 35 sessions of tRNS over fusiform temporal cortex
Placebo Comparator: tRNS with sham
This group receive 35 sessions with sham
Device: tRNS with sham
the subjects receive 35 session with sham

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

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004236

Contacts
Contact: Fernando Vargas-Torcal, PhD 966 61 69 00 vargas_fer@gva.es

Locations
Spain
General Elche Hospital Recruiting
Elche, Alicante, Spain, 03203
Principal Investigator: Fernando Vargas-Torcal, PhD         
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
Investigators
Study Chair: Moises Aguilar Domingo, PhD Spanish Foundation for Neurometrics Development
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT02004236     History of Changes
Other Study ID Numbers: Autism and tRNS
Study First Received: November 25, 2013
Last Updated: July 21, 2014
Health Authority: National Health Services: Spain
Community Health Services: Valencia

Keywords provided by Spanish Foundation for Neurometrics Development:
tRNS
QEEG
ERP
ASD
Autism
verbal fluency
empathy
noninvasive brain stimulation
tDCS

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014