Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

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

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders
• Intervention / Treatment: Device: Non-invasive Neuromodulation

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Palmas, Las
    • Las Palmas de Gran Canaria, Palmas, Las, Spain, 35018
      • Aníbal Báez Suárez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Non-invasive Neuromodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stool characteristics from baseline at a month and a half	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.	Baseline and up to 1 month, and two weeks after intervention
Change in sleep diary from baseline at a month and a half	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	Baseline and up to 1 month, and two weeks after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Las Palmas de Gran Canaria

Publications and helpful links

General Publications

• Thapar A, Cooper M, Rutter M. Neurodevelopmental disorders. Lancet Psychiatry. 2017 Apr;4(4):339-346. doi: 10.1016/S2215-0366(16)30376-5. Epub 2016 Dec 13.
• Ambartsumyan L, Rodriguez L. Gastrointestinal motility disorders in children. Gastroenterol Hepatol (N Y). 2014 Jan;10(1):16-26.
• Sood R, Ford AC. Diagnosis: Rome IV criteria for FGIDs - an improvement or more of the same? Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):501-2. doi: 10.1038/nrgastro.2016.110. Epub 2016 Jul 13. No abstract available.
• Robertson J, Baines S, Emerson E, Hatton C. Constipation management in people with intellectual disability: A systematic review. J Appl Res Intellect Disabil. 2018 Sep;31(5):709-724. doi: 10.1111/jar.12426. Epub 2017 Nov 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Electric Stimulation Therapy; physical therapy modality; Child Development Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Neurodevelopmental Disorders
• Other Study ID Numbers: NESA SJD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No