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Neurofunctional Rehabilitation and tDCS in children with Rubinstein-Taybi Syndrome

Neurofunctional Rehabilitation and Transcranial Direct Current Stimulation in children with Rubinstein-Taybi Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-73rpgs9
Enrollment
Unknown
Registered
2025-01-14
Start date
2024-12-05
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

Rubinstein-Taybi Syndrome

Interventions

Uncontrolled study with blinded evaluator. 15 children with Rubinstein-Taybi syndrome. Ten sessions of anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex (1mA)
E02.331.750

Sponsors

Irmandade da Santa Casa de Misericórdia de São Paulo
Lead Sponsor
Centro de Neuroestimulação Pediátrica
Collaborator

Eligibility

Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children with Rubinstein-Taybi Syndrome; no brain injuries; age between three and six years; degree of collaboration compatible with adequate performance in the activities proposed in this project; statement of informed consent signed by a legal guardian and statement of informed assent signed by the participant

Exclusion criteria

Exclusion criteria: Neurological or neuromuscular diseases associated with Rubinstein-Taybi Syndrome; 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
It is expected to find a reduction in neuropsychomotor development delay, assessed by the Bayley Scales of Infant and Toddler Development III, demonstrated by a 5% increase in the score of language items after the intervention. Data collected one week before the intervention and one and twelve weeks after the intervention;It is expected to find an increase in functional performance with increased independence in daily activities, demonstrated by an increase of 5 points in the Pediatric Evaluation of Disability Inventor after the interventions. Data collected one week before the intervention and one and twelve weeks after the intervention;It is expected to find an increase in participation, assessed by the Participation and Environment Measure for Children and Youth demonstrated by a 5% increase in scores after the interventions. Data collected one week before the intervention and one and twelve weeks after the intervention

Secondary

MeasureTime frame
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 ContactVeronica Unzueta

Faculdade de Ciências Médicas da Santa Casa de São Paulo

vero.palenqueunzueta@gmail.com+55 (11) 992199048

Outcome results

None listed

Source: REBEC (via WHO ICTRP)