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The effect of direct current Neuromodulation in children with Autism

The effect of Transcranial Direct Current Stimulation combined with dual-task (language-motor) in children with Autism: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7drv297
Enrollment
24
Registered
2026-02-12
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Interventions

This was a two-arm, double-blind, randomized controlled clinical trial that initially included 24 children, of which only 17 participants completed the study, with 9 participants allocated to the expe

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Universidade Federal do Amazonas
Collaborator

Eligibility

Age
2 Years to 3 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed by the Modified Checklist for Autism in Toddlers (M-CHAT) and a medical referral for speech-language therapy; symptomatic severity of ASD classified as Level I or II of support, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); both sexes; normal hearing, as confirmed by a Brainstem Auditory Evoked Potential (BAEP) test; age range from 2 to 3.5 years; not receiving any other concurrent multidisciplinary therapies alongside the research; absence of a cardiac pacemaker, metallic or electronic implant in the body; absence of epilepsy or seizure disorders; absence of other additional disorders or pathologies, such as Down syndrome, Cerebral Palsy, confirmed genetic syndromes, West syndrome, among others

Exclusion criteria

Exclusion criteria: Refusal of the responsible party to sign the informed consent form; low participant tolerance to the intervention, participant refusal of Transcranial Direct Current Stimulation (tDCS) or linguistic-motor therapy; having an interval greater than 3 consecutive days without intervention or 4 staggered days

Design outcomes

Secondary

MeasureTime frame
It is expected to see better Bayley scale evaluative scores after 10 days of intervention;It is expected to see better scores on the (PROC) behavior observation protocol after 10 days of intervention

Primary

MeasureTime frame
It is expected that transcranial anodal direct current stimulation (tDCS) in the primary motor area associated with dual-task activities (linguistic-motor) will positively influence the acquisition of language skills for children with autism (ASD), after 10 days of stimulation;t is expected that participants demonstrate improved performance in expressive and receptive language following the sessions, thereby serving as a foundation for developing new therapeutic approaches for children on the autism spectrum. If it is confirmed that neuromodulation (electrical head stimulation) contributes to enhanced speech when combined with a dual-task of speech and gait, this will represent a significant advancement in the clinical field, offering the possibility of adopting this therapeutic strategy to improve the development of children with autism

Countries

Brazil

Contacts

Public ContactJorciane Soares

Universidade Federal do Amazonas

costajorciane@gmail.com+55(92)3305-1480

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026