Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2022-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

NCT06608576

High-risk Infants

ENROLLING_BY_INVITATION NA

Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders

NCT06092619

Motor Disorders

UNKNOWN NA

Enhancing Sensorimotor Processing in Children With Dystonia

NCT05612464

Dystonic Cerebral Palsy Dystonia, Secondary Dystonia +2 more

NOT_YET_RECRUITING

Early Childhood Constraint Therapy in Cerebral Palsy

NCT02567630

Cerebral Palsy

UNKNOWN NA

Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children

NCT03521427

Cerebral Palsy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurodevelopmental Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-invasive Neuromodulation

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

Group Type EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No