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

Primary Purpose

Autism, ASD

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
tRNS Fronto-temporal cortex
tRNS over fusiform temporal cortex
tRNS with sham
Sponsored by
Spanish Foundation for Neurometrics Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring tRNS, QEEG, ERP, ASD, Autism, verbal fluency, empathy, noninvasive brain stimulation, tDCS

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • General Elche Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

tRNS Fronto-temporal cortex

tRNS over fusiform temporal cortex

tRNS with sham

Arm Description

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

This group receive 35 sessions of tRNS over fusiform temporal cortex

This group receive 35 sessions with sham

Outcomes

Primary Outcome Measures

Verbal Fluency
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
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
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
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
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
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
ERP & Behaviour changes in ASD children after tRNS
Omission Errors Before tRNS
ERP and behaviour changes in ASD children before tRNS
Commission Errors Before tRNS
ERP and Behaviour changes in ASD children before tRNS
P3b Wave Amplitude Before tRNS
ERP and behaviour Changes in ASD children before tRNS
Reaction Time After tRNS
ERP and behaviour Changes in ASD children after tRNS
Ommision Errors After tRNS
ERP and behaviour Changes in ASD children after tRNS
Commission Errors After tRNS
ERP and behaviour Changes in ASD children after tRNS
P3b Wave Amplitude After tRNS
ERP and behaviour Changes in ASD children after tRNS

Full Information

First Posted
November 25, 2013
Last Updated
April 10, 2023
Sponsor
Spanish Foundation for Neurometrics Development
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1. Study Identification

Unique Protocol Identification Number
NCT02004236
Brief Title
Transcranial Random Noise Stimulation (tRNS) Over Fronto-temporal Cortex Improves Verbal Fluency and Empathy in Autism Children
Acronym
tRNS25112013
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Foundation for Neurometrics Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, ASD
Keywords
tRNS, QEEG, ERP, ASD, Autism, verbal fluency, empathy, noninvasive brain stimulation, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tRNS Fronto-temporal cortex
Arm Type
Experimental
Arm Description
This group receive 35 sessions of tRNS over fronto-temporal cortex
Arm Title
tRNS over fusiform temporal cortex
Arm Type
Experimental
Arm Description
This group receive 35 sessions of tRNS over fusiform temporal cortex
Arm Title
tRNS with sham
Arm Type
Placebo Comparator
Arm Description
This group receive 35 sessions with sham
Intervention Type
Device
Intervention Name(s)
tRNS Fronto-temporal cortex
Intervention Description
This group receive 35 sessions of tRNS over fronto-temporal cortex
Intervention Type
Device
Intervention Name(s)
tRNS over fusiform temporal cortex
Intervention Description
This group receive 35 sessions of tRNS over fusiform temporal cortex
Intervention Type
Device
Intervention Name(s)
tRNS with sham
Intervention Description
the subjects receive 35 session with sham
Primary Outcome Measure Information:
Title
Verbal Fluency
Description
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)
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Sociability
Description
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)
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Secondary Outcome Measure Information:
Title
Ratio Theta/Beta Before tRNS
Description
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.
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Theta Amplitude in T5 Before tRNS
Description
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.
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Ratio Theta/Beta After tRNS
Description
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.
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Theta Amplitude in T5 After tRNS
Description
Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Reaction Time in ECPT Before tRNS
Description
ERP & Behaviour changes in ASD children after tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Omission Errors Before tRNS
Description
ERP and behaviour changes in ASD children before tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Commission Errors Before tRNS
Description
ERP and Behaviour changes in ASD children before tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
P3b Wave Amplitude Before tRNS
Description
ERP and behaviour Changes in ASD children before tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Reaction Time After tRNS
Description
ERP and behaviour Changes in ASD children after tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Ommision Errors After tRNS
Description
ERP and behaviour Changes in ASD children after tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
Commission Errors After tRNS
Description
ERP and behaviour Changes in ASD children after tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions
Title
P3b Wave Amplitude After tRNS
Description
ERP and behaviour Changes in ASD children after tRNS
Time Frame
During 3 months of intensive speech therapy during tRNS sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
General Elche Hospital
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.dep20.san.gva.es/
Description
General Elche Hospital
URL
http://www.bigdata4brain.com
Description
Bigdata4brain LTD

Learn more about this trial

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

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