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

University of Las Palmas de Gran Canaria

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Device: Non-invasive Neuromodulation; Device: Placebo Non-invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06417450

NESATEA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with a diagnosis of Autistic Spectrum Disorder, attending school in the City 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 criteria

• Present some of the contraindications for treatment with NESA XSIGNAL®: pacemakers, internal haemorrhages, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity.
• If parents do not sign the informed consent form.
• Presence of uncontrolled convulsions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Non-invasive Neuromodulation

Experimental group

Description:

Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Treatment:

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Placebo Comparator group

Description:

Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Treatment:

Device: Placebo Non-invasive Neuromodulation