Clinical trial NCT06417450: Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: physical therapy modality
sleep disorder
Quality of Life
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in sleep quality with the Sleep Disturbance Scale for Children (SDSC)
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
measure: Measuring sleep habits with the Children's Sleep Habits Questionnaire scale
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
measure: Change in parent´s sleep quality with the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
Secondary outcomes:
measure: Changes to the Register of Disruptive Behaviour Scores with the Aberrant Behavior Checklist (ABC-C)
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
measure: Change in the stress level of parents with the Change in the stress level of parents
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
measure: Change in parental satisfaction with the Parent Satisfaction Questionnaire (PSQ - FS)
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment).
Other outcomes:
measure: Recording of adverse phenomena
timeFrame: From the start of treatment to the end of treatment (2 months)
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: University of Las Palmas de Gran Canaria
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parr J. Autism. BMJ Clin Evid. 2010 Jan 7;2010:0322.
citation: 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.
citation: 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.
citation: 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.