Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

Not Applicable

Completed

• Conditions: Neurodevelopmental Disorders
• Interventions: Device: Non-invasive Neuromodulation

• Registration Number: NCT05265702
• Lead Sponsor: University of Las Palmas de Gran Canaria

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-03
• Study Start: 2022-03-07
• Status Verified: 2022-04
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-27
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-invasive Neuromodulation	Non-invasive Neuromodulation	Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Primary Outcome Measures

Name	Time	Method
Change in stool characteristics from baseline at a month and a half	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.
Change in sleep diary from baseline at a month and a half	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 Outcome Measures

Name	Time	Method
Frequency of defecation from baseline at a month and a half	Baseline and up to 1 month, and two weeks after intervention	It will be recorded in number of times in which the participant defecates.

Trial Locations

Locations (1)

Aníbal Báez Suárez; 🇪🇸 Las Palmas de Gran Canaria, Palmas, Las, Spain