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

Last updated: March 24, 2025
Sponsor: University of Las Palmas de Gran Canaria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Autism

Williams Syndrome

Treatment

Placebo Non-invasive Neuromodulation

Non-invasive Neuromodulation

Clinical Study ID

NCT06417450
NESATEA
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children with a diagnosis of Autistic Spectrum Disorder, attending school in theCity of San Juan de Dios in Las Palmas de Gran Canaria.

  • Children with symptoms related to sleep disturbances.

  • Children who present episodes of disruptive behaviour.

  • Children who may present sensory alterations or cognitive deficits.

  • Children whose parents sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Present some of the contraindications for treatment with NESA XSIGNAL®: pacemakers,internal haemorrhages, not applying electrodes on skin in poor condition, withulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobiaof electricity.

  • If parents do not sign the informed consent form.

  • Presence of uncontrolled convulsions.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo Non-invasive Neuromodulation
Phase:
Study Start date:
May 13, 2024
Estimated Completion Date:
August 13, 2025

Study 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.

Connect with a study center

  • University of Las Palmas de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Active - Recruiting

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