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

NCT ID: NCT06417450

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2025-07-13

Brief 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

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Non-invasive Neuromodulation

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

Group Type: EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type: DEVICE

Patients receive non-invasive neurostimulation through the Nesa device

Placebo Non-invasive Neuromodulation

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

Group Type: PLACEBO_COMPARATOR

Placebo Non-invasive Neuromodulation

Intervention Type: DEVICE

The 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.

Interventions

Non-invasive Neuromodulation

Patients receive non-invasive neurostimulation through the Nesa device

Intervention Type: DEVICE

Placebo Non-invasive Neuromodulation

The 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: lead

Responsible Party

Aníbal Báez Suárez

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aníbal Báez Suárez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Las Palmas de Gran Canaria

Locations

University of Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Countries

Spain

References

Parr J. Autism. BMJ Clin Evid. 2010 Jan 7;2010:0322.

Reference Type: RESULT

PMID: 21729335 (View on PubMed)

Moss AH, Gordon JE, O'Connell A. Impact of sleepwise: an intervention for youth with developmental disabilities and sleep disturbance. J Autism Dev Disord. 2014 Jul;44(7):1695-707. doi: 10.1007/s10803-014-2040-y.

Reference Type: RESULT

PMID: 24442795 (View on PubMed)

Souders MC, Zavodny S, Eriksen W, Sinko R, Connell J, Kerns C, Schaaf R, Pinto-Martin J. Sleep in Children with Autism Spectrum Disorder. Curr Psychiatry Rep. 2017 Jun;19(6):34. doi: 10.1007/s11920-017-0782-x.

Reference Type: RESULT

PMID: 28502070 (View on PubMed)

Hirata I, Mohri I, Kato-Nishimura K, Tachibana M, Kuwada A, Kagitani-Shimono K, Ohno Y, Ozono K, Taniike M. Sleep problems are more frequent and associated with problematic behaviors in preschoolers with autism spectrum disorder. Res Dev Disabil. 2016 Feb-Mar;49-50:86-99. doi: 10.1016/j.ridd.2015.11.002. Epub 2015 Dec 10.

Reference Type: RESULT

PMID: 26672680 (View on PubMed)

Other Identifiers

NESATEA

Identifier Type: -

Identifier Source: org_study_id