Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT02004236
First received: November 25, 2013
Last updated: October 9, 2014
Last verified: October 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 ]

    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)


  • Sociability [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]

    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)



Secondary Outcome Measures:
  • Ratio Theta/Beta Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.

  • Theta Amplitude in T5 Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.

  • Ratio Theta/Beta After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.

  • Theta Amplitude in T5 After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old

  • Reaction Time in ECPT Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP & Behaviour changes in ASD children after tRNS

  • Omission Errors Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour changes in ASD children before tRNS

  • Commission Errors Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and Behaviour changes in ASD children before tRNS

  • P3b Wave Amplitude Before tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour Changes in ASD children before tRNS

  • Reaction Time After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour Changes in ASD children after tRNS

  • Ommision Errors After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour Changes in ASD children after tRNS

  • Commission Errors After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour Changes in ASD children after tRNS

  • P3b Wave Amplitude After tRNS [ Time Frame: During 3 months of intensive speech therapy during tRNS sessions ] [ Designated as safety issue: Yes ]
    ERP and behaviour Changes in ASD children after tRNS


Enrollment: 225
Study Start Date: January 2014
Study Completion Date: September 2014
Primary Completion Date: August 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

Locations
Spain
General Elche Hospital
Elche, Alicante, Spain, 03203
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
Results First Received: September 16, 2014
Last Updated: October 9, 2014
Health Authority: Spain: Ministry of Health

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
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on February 25, 2015