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

NCT06417450 | Completed

• 1 other identifier: NESATEA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

physical therapy modality; sleep disorder; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Change in sleep quality with the Sleep Disturbance Scale for Children (SDSC)

  The Sleep Disturbance Scale for Children (SDSC) will be used. The SDSC is a 26-item scale developed to assess the presence of sleep difficulties in children within the previous six months. The measure is completed by the parent of the child and takes approximately 5-10 min to complete. Item 1 measures the child's average hours of sleep, from 1 ('9 - 11 h') to 5 ('less than 5 h').

  Measurement of change: before treatment (baseline), at two months (end of treatment).

• Measuring sleep habits with the Children's Sleep Habits Questionnaire scale

  Each scored question is rated on a 3-point scale as occurring "usually" (i.e., 5-7 times within the past week), "sometimes" (i.e., 2-4 times within the past week), or "rarely" (i.e., never or 1 time within the past week).

  Measurement of change: before treatment (baseline), at two months (end of treatment).

• Change in parent´s sleep quality with the Pittsburgh Sleep Quality Index (PSQI)

  The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep

  Measurement of change: before treatment (baseline), at two months (end of treatment).

Secondary Outcomes (3)

• Changes to the Register of Disruptive Behaviour Scores with the Aberrant Behavior Checklist (ABC-C)

  Measurement of change: before treatment (baseline), at two months (end of treatment).

• Change in the stress level of parents with the Change in the stress level of parents

  Measurement of change: before treatment (baseline), at two months (end of treatment).

• Change in parental satisfaction with the Parent Satisfaction Questionnaire (PSQ - FS)

  Measurement of change: before treatment (baseline), at two months (end of treatment).

Other Outcomes (1)

• Recording of adverse phenomena

  From the start of treatment to the end of treatment (2 months)

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

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

Device: Placebo Non-invasive Neuromodulation

Interventions

Non-invasive Neuromodulation DEVICE

Patients receive non-invasive neurostimulation through the Nesa device

Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation 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.

Placebo Non-invasive Neuromodulation

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

University of Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related Publications (4)

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

  PMID: 21729335 RESULT

• 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.

  PMID: 24442795 RESULT

• 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.

  PMID: 28502070 RESULT

• 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.

  PMID: 26672680 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aníbal Báez Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: May 13, 2024
• Primary Completion: May 13, 2025
• Study Completion: July 13, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)