Autism Spectrum DisorderNCT06417450
Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders
A study testing Non-invasive Neuromodulation in people with Autism Spectrum Disorder, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2024to 13 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
University of Las Palmas de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
About this study
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.
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.
Read the 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
- Being tested
- Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
- Keywords
- physical therapy modality, sleep disorder, Quality of Life
- Medical subject headings
- Autism Spectrum Disorder, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
Patients receive non-invasive neurostimulation through the Nesa device
Placebo Non-invasive NeuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: 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. Receives: Device: Placebo Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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).
Measured: 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
Measured: 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)
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).
Measured: 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
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.
Measured: Measurement of change: before treatment (baseline), at two months (end of treatment).
Change in parental satisfaction with the Parent Satisfaction Questionnaire (PSQ - FS)
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
Measured: Measurement of change: before treatment (baseline), at two months (end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 May 2024
- Primary completion13 May 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez Suárez, PhD, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417450
- Sponsor's protocol ID
- NESATEA
- Status last verified
- Aug 2025
- First submitted
- 13 May 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parr J. Autism. BMJ Clin Evid. 2010 Jan 7;2010:0322.
PubMed 21729335Moss 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.
PubMed 24442795Souders 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.
PubMed 28502070Hirata 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.
PubMed 26672680
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06417450
- Acronym / sponsor ID
- NESATEA
- Conditions
- Autism Spectrum Disorder
- Keywords
- physical therapy modality, sleep disorder, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationIntervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Device: Placebo Non-invasive NeuromodulationIntervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationPatients receive non-invasive neurostimulation through the Nesa device | Device | Non-invasive Neuromodulation |
| Placebo Non-invasive NeuromodulationThe 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. | Device | Placebo Non-invasive Neuromodulation |
Primary outcome
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').
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).
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
3 secondary outcomes
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 21729335Parr J. Autism. BMJ Clin Evid. 2010 Jan 7;2010:0322.
- Results publication: PubMed 24442795Moss 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.
- Results publication: PubMed 28502070Souders 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.
- Results publication: PubMed 26672680Hirata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aníbal Báez Suárez, PhD principal investigator
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Autism Spectrum Disorder, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417450, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.