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Facilitation of brain activity and motor training in children with autism spectrum disorder

Facilitation of left dorsolateral prefrontal activity using tDCS and neurofunctional training in children with autism spectrum disorder: a randomized, placebo-controlled, double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3frh5bp
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-10-16
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Autism Spectrum Disorder

Interventions

Sponsors

Universidade Evangélica de Goiás
Lead Sponsor
Follow Kids - Clinica de Neuro Reabilitação Infantil
Collaborator

Eligibility

Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Diagnosis of autism spectrum disorder confirmed through clinical examination; have a standardized neurobehavioral assessment that confirms and categorizes the severity of autism spectrum disorder; children levels I, II and III according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); age between three and eight years of age; children who demonstrate sufficient response to understand simple verbal commands; no medication changes at least six months before the start of the study and during its execution; statement of informed consent signed by a legal guardian and statement of informed assent signed by the participant

Exclusion criteria

Exclusion criteria: Children that having been submitted to surgical procedures or neurolytic block in the 12 months prior to the onset of the training sessions; orthopedic deformities with indication for surgery; epilepsy; metal implants in skull or hearing aids; intellectual disorder that would limit the execution of the intellectual activities proposed in the study

Design outcomes

Primary

MeasureTime frame
Mobility and functional balance assessed by the execution time of the timed up and go test (seconds) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find a decrease in the test execution time after the interventions.

Secondary

MeasureTime frame
Time and space parameters of gate evaluated by the walk test (m/s) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in gait speed to perform the test after the interventions.;Functional balance assessed by the Pediatric Balance Scale (points) applied one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in the total score of the scale, demonstrating an improvement in functional balance, with a greater effect size for group receiving active galvanic vestibular stimulation compared to sham galvanic vestibular stimulation.;Characteristics of autistic behavior evaluated by the Childhood Autism Rating Scale which is an observation scale that will be applied with the person responsible for the participant. The scale will be applied one week before and four and eight weeks after the end of the intervention. It is expected to find a reduction in the severity of autistic symptoms observed by those responsible for the child after the interventions.;Adverse effects assessed using a standardized questionnaire that quantifies the perception and intensity of symptoms. Assessments performed before and after each of the ten intervention sessions. It is expected not to find moderate or severe adverse effects during the intervention period.

Countries

Brazil

Contacts

Public ContactLuanda Collange

Centro de Neuroestimulação Pediátrica

luandacollange@hotmail.com+55(11)3667-6795

Outcome results

None listed

Source: REBEC (via WHO ICTRP)