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Completed

NCT Number: NCT06417450

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Las Palmas de Gran Canaria

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Neuromodulation

Device

Patients receive non-invasive neurostimulation through the Nesa device

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.

Primary outcomes

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

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

    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').

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

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

    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).

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

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

    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

Secondary outcomes

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

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

    The Aberrant Behavior Checklist (ABC-C) is a 58-item rating scale derived by factor analysis, and its five subscales are labelled as follows: I- Irritability (15 items); II- inactivity-isolation (16 items); III- stereotypies (7 items); IV- Hyperactivity, non-compliance (16 items) and V- inappropriate language (4 items). The ABC-C is easy to use, it is completed by an informant such as a teacher, therapist, monitor, parent or other adult who has regular contact with the patient. Each behavioural item is rated on a four-point scale from 0 (not a problem) to 3 (problem is severe).

  2. Change in the stress level of parents with the Change in the stress level of parents

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

    The Parenting Stress Index-Short Form (PSI-SF) is one of the most commonly used measures of parenting stress both in clinical and research contexts. The PSI-SF is a 36-item, self-report measure with three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (PCDI), and Difficult Child (DC).

    To compute the parental stress score, items 1, 2, 5, 6, 7, 8, 17, and 18 should be reverse scored as follows: (1=5) (2=4) (3=3) (4=2) (5=1). The item scores are then summed. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

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

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

    The 19-item PSQ assesses parents' cognitions and perceptions regarding the degree and kind of support they provide to their child following the discovery of sexual abuse. The measure yields a total score and scores on Support and Blame subscales

Other outcomes

  1. Recording of adverse phenomena

    Time frame: From the start of treatment to the end of treatment (2 months)

    The responses experienced by the participant will be observed during the session. As the procedure is sensory imperceptible and easy to handle, it will allow the participant to carry out activities (school/rehabilitation) simultaneously.

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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