Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265702
• Other study ID #: NESA SJD
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: April 27, 2022

Study information

• Verified date: April 2022
• Source: University of Las Palmas de Gran Canaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 27, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Neurodevelopmental Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Aníbal Báez Suárez	Las Palmas de Gran Canaria	Palmas, Las

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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