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Completed

NCT Number: NCT05265702

Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

Children with neurodevelopmental disorders have a delay in acquiring the skills that are assumed considering the phases of typical psychomotor development. Added to this difficulty and main element of concern on the part of their families, there are another series of signs that appear with some frequency and that, despite being unnoticed against other major problems represent basic and fundamental factors in the correct development and performance such as constipation problems and sleep disorders.

The aim of the study consists of to evaluate the effectiveness and safety of the non-invasive neuromodulation device applied in people with neurodevelopmental disorders, in relation to constipation problems and in the quality of sleep.

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Key information

Conditions

Neurodevelopmental Disorders Developmental Disabilities Mental Disorders

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aníbal Báez Suárez

Las Palmas de Gran Canaria, Palmas, Las, 35018, Spain

About this study

While the application is being sent to the ethics committee, we will hold a series of informative talks for the centre's staff who, in one way or another, will be involved in the development of the project.

At the same time, information letters will be sent to the parents or legal representatives of the children who will a priori be part of the project, as well as the corresponding informed consent. In addition, they will be sent the screening documents that will allow us to confirm if the selected subject has constipation problems and/or sleep disorders.

The intervention period per subject will be 12 sessions, distributed in three sessions per week (Monday, Wednesday, and Friday), estimating that the intervention can be completed after one month.

During school hours, the participants will receive their own treatment, agreed by their multidisciplinary team with common and personal objectives for the subjects, so that there will be no interruption of their usual routine.

Two weeks after the intervention, a new assessment will be carried out to assess whether the possible changes recorded during the intervention phase have been maintained.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sensory-motor alteration.
  • Be schooled in the Center of the City San Juan de Dios of Las Palmas de Gran Canaria.
  • Meet the criteria established by the Rome IV constipation scale.
  • Informed consent signed by the family, guardian or legal representative.

Exclusion criteria

  • No contraindications to treatment with NXSignal: Pacemaker, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity.
  • Epilepsia.
  • Subjects who modify eating habits and/or water intake.

Treatment and study plan

Non-invasive Neuromodulation

Device

The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 12 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.

Primary outcomes

  1. Change in stool characteristics from baseline at a month and a half

    Time frame: Baseline and up to 1 month, and two weeks after intervention

    A daily evaluation will be carried out both number of stools, as well as the type of stools following the criteria established by the Bristol Stool Form Scale. It is widely used as a research tool to assess the efficacy of treatments for various diseases of the intestine. The chart is used to describe the shapes and types of stool. It is also used as a tool to diagnose constipation, diarrhea, and irritable bowel syndrome.

    It is a medical aid designed to classify faeces into seven groups: Types 1 and 2 indicate constipation, types 3 and 4 are considered healthy stool, while types 5 to 7 suggest diarrhea and urgency.

    Each person will have different bowel habits, but the important thing is that your stools are soft and easy to pass, like types 3 and 4.

  2. Change in sleep diary from baseline at a month and a half

    Time frame: Baseline and up to 1 month, and two weeks after intervention

    The sleep diary is easy to complete and gives us a global vision of sleep for several days. It facilitates the calculation of hours of sleep and nocturnal awakenings.

    The person who registers indicates the number of hours of sleep

Secondary outcomes

  1. Frequency of defecation from baseline at a month and a half

    Time frame: Baseline and up to 1 month, and two weeks after intervention

    It will be recorded in number of times in which the participant defecates.

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

Effectiveness of Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders to Improve Constipation and Sleep Quality

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
May 3, 2022

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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