Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

NCT05265702 | Completed

• 1 other identifier: NESA SJD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Keywords

physical therapy modality; Electric Stimulation Therapy; Child Development Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Frequency of defecation from baseline at a month and a half

  Baseline and up to 1 month, and two weeks after intervention

Study Arms (1)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive Neuromodulation

Interventions

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.

Non-invasive Neuromodulation

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

Aníbal Báez Suárez

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

Location

Related Publications (5)

• 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.

  PMID: 27979720 RESULT

• Ambartsumyan L, Rodriguez L. Gastrointestinal motility disorders in children. Gastroenterol Hepatol (N Y). 2014 Jan;10(1):16-26.

  PMID: 24799835 RESULT

• 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.

  PMID: 27407043 RESULT

• 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.

  PMID: 29168259 RESULT

• Baez-Suarez A, Padron-Rodriguez I, Castellano-Moreno E, Gonzalez-Gonzalez E, Quintana-Montesdeoca MP, Medina-Ramirez RI. Application of non-invasive neuromodulation in children with neurodevelopmental disorders to improve their sleep quality and constipation. BMC Pediatr. 2023 Sep 15;23(1):465. doi: 10.1186/s12887-023-04307-4.

  PMID: 37715152 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Developmental Disabilities

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Aníbal Báez-Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 3, 2022
• Study Start: March 7, 2022
• Primary Completion: April 7, 2022
• Study Completion: April 27, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)