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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tRNS Fronto-temporal cortex | Experimental | This group receive 35 sessions of tRNS over fronto-temporal cortex |
|
| tRNS over fusiform temporal cortex | Experimental | This group receive 35 sessions of tRNS over fusiform temporal cortex |
|
| tRNS with sham | Placebo Comparator | This group receive 35 sessions with sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tRNS Fronto-temporal cortex | Device | This group receive 35 sessions of tRNS over fronto-temporal cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During 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) | During 3 months of intensive speech therapy during tRNS sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio Theta/Beta Before tDCS | 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. | During 3 months of intensive speech therapy during tRNS sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Neville, MD | New Remedies Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Remedies Ltd | Liverpool | Merseyside | L1 0AH | United Kingdom | ||
| Moises Aguilar Domingo |
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| Label | URL |
|---|---|
| Bigdata4brain LTD | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | tRNS Over Fronto-temporal Cortex | This group receive 35 sessions of tRNS over fronto-temporal cortex tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex |
| FG001 | tRNS Over Fusiform Temporal Cortex | This group receive 35 sessions of tRNS over fusiform temporal cortex tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex |
| FG002 | tRNS With Sham | This group receive 35 sessions with sham tRNS with sham: the subjects receive 35 session with sham |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Clinically referred sample of young children between 5 and 12 years old with ASD
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| ID | Title | Description |
|---|---|---|
| BG000 | tRNS Fronto-temporal Cortex | This group receive 35 sessions of tRNS over fronto-temporal cortex tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex |
| BG001 | tRNS Over Fusiform Temporal Cortex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions. | Posted | Mean | Standard Deviation | units on a scale | During 3 months of intensive speech therapy during tRNS sessions |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tRNS Fronto-temporal Cortex | This group receive 35 sessions of tRNS over fronto-temporal cortex tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Dizziness | Systematic Assessment | The children are disorientated in time and space at least during 1 or 2 hours after tRNS session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moises Domingo president of Brainmech Foundation | BrainMech Foundation | +441615312645 | moises@bigdata4brain.co.uk |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| tRNS over fusiform temporal cortex | Device | This group receive 35 sessions of tRNS over fusiform temporal cortex |
|
| tRNS with sham | Device | the subjects receive 35 session with sham |
|
| Theta Amplitude in T5 Before tDCS | 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. | During 3 months of intensive speech therapy during tRNS sessions |
| Ratio Theta/Beta After tDCS | 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 tDCS intervention in ASD children between 5 and 12 years old. | During 3 months of intensive speech therapy during tDCS sessions |
| Theta Amplitude in T5 After tDCS | Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old | During 3 months of intensive speech therapy during tRNS sessions |
| Reaction Time in ECPT Before tDCS | ERP & Behaviour changes in ASD children after tDCS | During 3 months of intensive speech therapy during tRNS sessions |
| Omission Errors Before tDCS | ERP and behaviour changes in ASD children before tDCS | During 3 months of intensive speech therapy during tRNS sessions |
| Commission Errors Before tDCS | ERP and Behaviour changes in ASD children before tDCS | During 3 months of intensive speech therapy during tDCS sessions |
| P3b Wave Amplitude Before tDCS | ERP and behaviour Changes in ASD children before tDCS | During 3 months of intensive speech therapy during tRNS sessions |
| Reaction Time After tDCS | ERP and behaviour Changes in ASD children after tDCS | During 3 months of intensive speech therapy during tDCS sessions |
| Omissions Errors After tDCS | ERP and behaviour Changes in ASD children after tDCS | During 3 months of intensive speech therapy during tDCS sessions |
| Commission Errors After tDCS | ERP and behaviour Changes in ASD children after tDCS | During 3 months of intensive speech therapy during tDCS sessions |
| P3b Wave Amplitude After tDCS | ERP and behaviour Changes in ASD children after tDCS | During 3 months of intensive speech therapy during tDCS sessions |
| Liverpool |
| Spain |
| L4 5QL |
| United Kingdom |
This group receive 35 sessions of tRNS over fusiform temporal cortex tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex |
| BG002 | tRNS With Sham | This group receive 35 sessions with sham tRNS with sham: the subjects receive 35 session with sham |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Age, Customized | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
This group receive 35 sessions of tRNS over fronto-temporal cortex tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex |
| OG001 | tRNS Over Fusiform Temporal Cortex | This group receive 35 sessions of tRNS over fusiform temporal cortex tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex |
| OG002 | tRNS With Sham | This group receive 35 sessions with sham tRNS with sham: the subjects receive 35 session with sham |
|
|
| Primary | 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) | Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions. | Posted | Mean | Standard Deviation | units on a scale | During 3 months of intensive speech therapy during tRNS sessions |
|
|
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| Secondary | Ratio Theta/Beta Before tDCS | 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. | Posted | Mean | Standard Deviation | Ratio theta/beta before tRNS | During 3 months of intensive speech therapy during tRNS sessions |
|
|
|
| Secondary | Theta Amplitude in T5 Before tDCS | 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. | Posted | Mean | Standard Deviation | MicroVolts | During 3 months of intensive speech therapy during tRNS sessions |
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| Secondary | Ratio Theta/Beta After tDCS | 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 tDCS intervention in ASD children between 5 and 12 years old. | Posted | Mean | Standard Deviation | Ratio theta/beta after tRNS | During 3 months of intensive speech therapy during tDCS sessions |
|
|
|
| Secondary | Theta Amplitude in T5 After tDCS | Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old | Posted | Mean | Standard Deviation | MicroVolts | During 3 months of intensive speech therapy during tRNS sessions |
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| Secondary | Reaction Time in ECPT Before tDCS | ERP & Behaviour changes in ASD children after tDCS | Posted | Mean | Standard Deviation | Milliseconds | During 3 months of intensive speech therapy during tRNS sessions |
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| Secondary | Omission Errors Before tDCS | ERP and behaviour changes in ASD children before tDCS | Posted | Mean | Standard Deviation | number of errors during ECPT task | During 3 months of intensive speech therapy during tRNS sessions |
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| Secondary | Commission Errors Before tDCS | ERP and Behaviour changes in ASD children before tDCS | Posted | Median | Standard Deviation | number of omission errors VCPT task | During 3 months of intensive speech therapy during tDCS sessions |
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| Secondary | P3b Wave Amplitude Before tDCS | ERP and behaviour Changes in ASD children before tDCS | Posted | Mean | Standard Deviation | MicroVolts or Amplitude P3b wave | During 3 months of intensive speech therapy during tRNS sessions |
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| Secondary | Reaction Time After tDCS | ERP and behaviour Changes in ASD children after tDCS | Posted | Mean | Standard Deviation | Reaction Time measuring in Milliseconds | During 3 months of intensive speech therapy during tDCS sessions |
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| Secondary | Omissions Errors After tDCS | ERP and behaviour Changes in ASD children after tDCS | Posted | Mean | Standard Deviation | number of omission errors in VCPT task | During 3 months of intensive speech therapy during tDCS sessions |
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| Secondary | Commission Errors After tDCS | ERP and behaviour Changes in ASD children after tDCS | Posted | Mean | Standard Deviation | number of commission errors in VCPT task | During 3 months of intensive speech therapy during tDCS sessions |
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| Secondary | P3b Wave Amplitude After tDCS | ERP and behaviour Changes in ASD children after tDCS | Posted | Mean | Standard Deviation | MicroVolts or Amplitude P3b wave | During 3 months of intensive speech therapy during tDCS sessions |
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| 0 |
| 75 |
| 1 |
| 75 |
| EG001 | tRNS Over Fusiform Temporal Cortex | This group receive 35 sessions of tRNS over fusiform temporal cortex tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex | 0 | 75 | 2 | 75 |
| EG002 | tRNS With Sham | This group receive 35 sessions with sham tRNS with sham: the subjects receive 35 session with sham | 0 | 59 | 0 | 59 |
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