Neurodevelopmental DisordersNCT05265702
Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders
A study testing Non-invasive Neuromodulation in people with Neurodevelopmental Disorders, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2022to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Non-invasive Neuromodulation
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Child Development Disorders
- Medical subject headings
- Neurodevelopmental Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: Device: Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
It will be recorded in number of times in which the participant defecates.
Measured: Baseline and up to 1 month, and two weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start7 Mar 2022
- Primary completion7 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez-Suárez, PhD, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265702
- Sponsor's protocol ID
- NESA SJD
- Status last verified
- Apr 2022
- First submitted
- 18 Feb 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27979720Ambartsumyan L, Rodriguez L. Gastrointestinal motility disorders in children. Gastroenterol Hepatol (N Y). 2014 Jan;10(1):16-26.
PubMed 24799835Sood 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.
PubMed 27407043Robertson 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.
PubMed 29168259Baez-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.
PubMed 37715152
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders to Improve Constipation and Sleep Quality
- ClinicalTrials.gov ID
- NCT05265702
- Acronym / sponsor ID
- NESA SJD
- Conditions
- Neurodevelopmental Disorders
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Child Development Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationNon-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThe 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. | Device | Non-invasive Neuromodulation |
Primary outcome
Change in stool characteristics from baseline at a month and a half
Time frame: Baseline and up to 1 month, and two weeks after intervention
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.
Change in sleep diary from baseline at a month and a half
Time frame: Baseline and up to 1 month, and two weeks after intervention
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
1 secondary outcome
Frequency of defecation from baseline at a month and a half
Time frame: Baseline and up to 1 month, and two weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Results publication: PubMed 27979720Thapar 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.
- Results publication: PubMed 24799835Ambartsumyan L, Rodriguez L. Gastrointestinal motility disorders in children. Gastroenterol Hepatol (N Y). 2014 Jan;10(1):16-26.
- Results publication: PubMed 27407043Sood 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.
- Results publication: PubMed 29168259Robertson 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.
- Derived from this study: PubMed 37715152Baez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aníbal Báez-Suárez, PhD principal investigator
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Neurodevelopmental Disorders, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool characteristics from baseline at a month and a half (time frame: Baseline and up to 1 month, and two weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265702, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.