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Neurostimulation for Cognitive Rehabilitation in Autistic Spectrum Disorders

NCT03947086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-15

No results posted yet for this study

Summary

This study is a clinical trial aims investigate the effects of neurostimulation in the treatment of children with mild ASD, specifically the action of tDCS on social cognition skills. tDCS can modulate neuronal activity in patients with ASD. Specifically, this technique has shown to be a promising tool in the promotion of social neuroplasticity, aiming at more adaptive social interactions. In this sense, it was hypothesized that participants treated with active tDCS will present better performance in social cognition tests than those submitted to sessions with simulated current.

Conditions

  • Autistic Disorders Spectrum

Interventions

DEVICE

Transcranial Direct Current Stimulation (TDCS)- Active

A constant current stimulator (TCT Research Limited) will be used using electrodes of 5 × 5 cm2 embedded in saline (0.9 % NaCl) and application of 1.5 mA current for 20 minutes for 5 consecutive days. The cathode will be positioned in the right supra-orbital region, and while the anode will have the following provision in the left dorsolateral prefrontal cortex (F3).

DEVICE

Transcranial Direct Current Stimulation (TDCS)- Sham

The protocol for participants receiving simulated current is identical, but the device ceases to emit current after 30 seconds of initiation of pacing.

BEHAVIORAL

Cognitive Training

Considering that the effects of TDCS are potentiated when applied during the execution of a task (online) (Miniussi, \& Ruzzoli, 2013), in the present study all participants received cognitive training, performed concomitantly with neurostimulation. Cognitive training consists of two parts: standardized tasks directed to social cognition and activities that stimulate executive functions. The first part consists of tasks contained in a battery of social games (Gao \& Maurer, 2009; Dillon, Kannan, Dean, Spelke, \& Duflo, 2017). While the tasks directed to the executive domain are, namely: running mazes, assembling figures, completing parts of figures and the Super Lynx Memory Game. All participants, regardless of whether they underwent active or simulated stimulation, received cognitive training, respecting the ethical principles of ensuring therapeutic assistance to those involved.

Sponsors & Collaborators

  • Federal University of Paraíba

    lead OTHER

Principal Investigators

  • Jéssica B Santana, Master · Federal University of Paraíba

  • Natanael A Santos, PhD · Federal University of Paraíba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2018-09-30
Completion
2019-05-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947086 on ClinicalTrials.gov