Clinical trial NCT05265702: Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders
Official title: Effectiveness of Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders to Improve Constipation and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: physical therapy modality
Electric Stimulation Therapy
Child Development Disorders
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in stool characteristics from baseline at a month and a half
timeFrame: Baseline and up to 1 month, and two weeks after intervention
measure: Change in sleep diary from baseline at a month and a half
timeFrame: Baseline and up to 1 month, and two weeks after intervention
Secondary outcomes:
measure: Frequency of defecation from baseline at a month and a half
timeFrame: Baseline and up to 1 month, and two weeks after intervention
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Aníbal Báez Suárez
state: Palmas, Las
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez-Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Ambartsumyan L, Rodriguez L. Gastrointestinal motility disorders in children. Gastroenterol Hepatol (N Y). 2014 Jan;10(1):16-26.
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. No abstract available.
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.