Clinical Trials Directory

Trials / Completed

CompletedNCT06417450

Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders

Utility of NESA Microcurrents in the Treatment of Sleep Disturbances, Disruptive Behaviours of Children With Autism Spectrum Disorders and in the Quality of Life of the Family Unit.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Las Palmas de Gran Canaria · Academic / Other
Sex
All
Age
2 Years – 18 Years
Healthy volunteers
Not accepted

Summary

The term or definition of Autism Spectrum Disorder (ASD) defines a pervasive neurodevelopmental disorder in which deficits in communication and social interaction, altered sensorimotor behaviours, repetitive, restricted and stereotyped interests and activities are observed. One of the disorders most frequently associated with ASD, and which most affects the quality of life of the child and his or her family, is sleep disorders; it is estimated that between 50 and 80 percent of children with ASD present this alteration and generally continue to suffer from it in adolescence and adulthood; It has also been observed that there is a correlation between sleep problems and an increase in aggressive behaviour, social and emotional deficits and deficits in activities of daily living, which severely affects the child and his or her close family environment; they become emotionally destabilised in a notorious way, and this has a negative impact on their work and productive environment. The microcurrents generated by the non-invasive neuromodulation device introduce, by means of a non-invasive technique (surface electrodes), electrical energy to normalise the nervous stimulus. This makes it an excellent complementary treatment to the activity of rehabilitation treatment. Its effects are achieved by establishing several input nerve pathways corresponding to the body's dermis, through which the signals are intellectualised in time-space. These signals are the basis for achieving normalisation of the nerve impulse by means of microcurrents.

Detailed description

The main objective will be to test the influence of surface neuromodulation applied NESA on sleep disturbances in children with Autism Spectrum Disorders and how this is related to disruptive behaviours and quality of life in the family environment. It is estimated to take 8 months from the design, management and development of the project, and does not have sources of funding.

Conditions

Interventions

TypeNameDescription
DEVICENon-invasive NeuromodulationPatients receive non-invasive neurostimulation through the Nesa device
DEVICEPlacebo Non-invasive NeuromodulationThe same protocol described for the experimental group will be applied, but electrical stimulation device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Timeline

Start date
2024-05-13
Primary completion
2025-05-13
Completion
2025-07-13
First posted
2024-05-16
Last updated
2025-08-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06417450. Inclusion in this directory is not an endorsement.