AutismtDCS25112013NCT02004236
Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids
A study testing tRNS Fronto-temporal cortex and tRNS over fusiform temporal cortex in people with Autism and ASD, run by Spanish Foundation for Neurometrics Development at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- What is being tested?
- tRNS Fronto-temporal cortex and tRNS over fusiform temporal cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Acute visual or hearing loss.
- Traumatic brain injury.
- Other neurological disorders: migraine, epilepsy, tuberous sclerosis ...
- Trauma at birth.
- Mental retardation.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
New Remedies Ltd
Liverpool, Merseyside, L1 0AH
Moises Aguilar Domingo
Liverpool, Spain, L4 5QL
About this study
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
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.
Read the 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.
- Being tested
- tRNS Fronto-temporal cortex, tRNS over fusiform temporal cortex, tRNS with sham
- Keywords
- tDCS, QEEG, ERP, ASD, Autism, verbal fluency, empathy, noninvasive brain stimulation
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tRNS Fronto-temporal cortexDevice
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS over fusiform temporal cortexDevice
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS with shamDevice
the subjects receive 35 session with sham
| Study group | Role | What they receive |
|---|---|---|
| tRNS Fronto-temporal cortex | Experimental | This group receive 35 sessions of tRNS over fronto-temporal cortex Receives: Device: tRNS Fronto-temporal cortex |
| tRNS over fusiform temporal cortex | Experimental | This group receive 35 sessions of tRNS over fusiform temporal cortex Receives: Device: tRNS over fusiform temporal cortex |
| tRNS with sham | Placebo comparator | This group receive 35 sessions with sham Receives: Device: tRNS with sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: During 3 months of intensive speech therapy during tRNS sessions
Secondary outcomes (12)
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.
Measured: During 3 months of intensive speech therapy during tRNS sessions
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.
Measured: 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.
Measured: 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
Measured: During 3 months of intensive speech therapy during tRNS sessions
Reaction Time in ECPT Before tDCS
ERP \& Behaviour changes in ASD children after tDCS
Measured: During 3 months of intensive speech therapy during tRNS sessions
Omission Errors Before tDCS
ERP and behaviour changes in ASD children before tDCS
Measured: During 3 months of intensive speech therapy during tRNS sessions
Commission Errors Before tDCS
ERP and Behaviour changes in ASD children before tDCS
Measured: During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude Before tDCS
ERP and behaviour Changes in ASD children before tDCS
Measured: During 3 months of intensive speech therapy during tRNS sessions
Reaction Time After tDCS
ERP and behaviour Changes in ASD children after tDCS
Measured: During 3 months of intensive speech therapy during tDCS sessions
Omissions Errors After tDCS
ERP and behaviour Changes in ASD children after tDCS
Measured: During 3 months of intensive speech therapy during tDCS sessions
Commission Errors After tDCS
ERP and behaviour Changes in ASD children after tDCS
Measured: During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude After tDCS
ERP and behaviour Changes in ASD children after tDCS
Measured: During 3 months of intensive speech therapy during tDCS sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Neville, MD, Principal investigator, New Remedies Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004236
- Sponsor's protocol ID
- Autism and tDCS
- Acronym
- tDCS25112013
- Status last verified
- May 2024
- First submitted
- 25 Nov 2013
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02004236
- Acronym / sponsor ID
- tDCS25112013 / Autism and tDCS
- Keywords
- tDCS, QEEG, ERP, ASD, Autism, verbal fluency, empathy, noninvasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tRNS Fronto-temporal cortex | Experimental | Device: tRNS Fronto-temporal cortexThis group receive 35 sessions of tRNS over fronto-temporal cortex |
| tRNS over fusiform temporal cortex | Experimental | Device: tRNS over fusiform temporal cortexThis group receive 35 sessions of tRNS over fusiform temporal cortex |
| tRNS with sham | Placebo comparator | Device: tRNS with shamThis group receive 35 sessions with sham |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Acute visual or hearing loss.
- Traumatic brain injury.
- Other neurological disorders: migraine, epilepsy, tuberous sclerosis ...
- Trauma at birth.
- Mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tRNS Fronto-temporal cortexThis group receive 35 sessions of tRNS over fronto-temporal cortex | Device | tRNS Fronto-temporal cortex |
| tRNS over fusiform temporal cortexThis group receive 35 sessions of tRNS over fusiform temporal cortex | Device | tRNS over fusiform temporal cortex |
| tRNS with shamthe subjects receive 35 session with sham | Device | tRNS with sham |
Primary outcome
Verbal Fluency
Time frame: During 3 months of intensive speech therapy during tRNS sessions
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
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)
12 secondary outcomes
Ratio Theta/Beta Before tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Theta Amplitude in T5 Before tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Ratio Theta/Beta After tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
Theta Amplitude in T5 After tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Reaction Time in ECPT Before tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Omission Errors Before tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Commission Errors Before tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude Before tDCS
Time frame: During 3 months of intensive speech therapy during tRNS sessions
Reaction Time After tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
Omissions Errors After tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
Commission Errors After tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
P3b Wave Amplitude After tDCS
Time frame: During 3 months of intensive speech therapy during tDCS sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Bigdata4brain LTDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Neville, MD principal investigator
New Remedies Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tRNS Fronto-temporal cortex and tRNS over fusiform temporal cortex in people with Autism and ASD, run by Spanish Foundation for Neurometrics Development at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Fluency (time frame: During 3 months of intensive speech therapy during tRNS sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.