Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417450
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Usefulness of NESA Microcurrents in the Treatment of Children with Autism Spectrum Disorders
Sponsor:
University of Las Palmas de Gran Canaria
Organization:
University of Las Palmas de Gran Canaria
Study Overview
Official Title:
Utility of NESA Microcurrents in the Treatment of Sleep Disturbances Disruptive Behaviours of Children with Autism Spectrum Disorders and in the Quality of Life of the Family Unit
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The term or definition of Autism Spectrum Disorder ASD defines a pervasive neurodevelopmental disorder in which deficits in communication and social interaction altered sensorimotor behaviours repetitive restricted and stereotyped interests and activities are observed
One of the disorders most frequently associated with ASD and which most affects the quality of life of the child and his or her family is sleep disorders it is estimated that between 50 and 80 percent of children with ASD present this alteration and generally continue to suffer from it in adolescence and adulthood It has also been observed that there is a correlation between sleep problems and an increase in aggressive behaviour social and emotional deficits and deficits in activities of daily living which severely affects the child and his or her close family environment they become emotionally destabilised in a notorious way and this has a negative impact on their work and productive environment
The microcurrents generated by the non-invasive neuromodulation device introduce by means of a non-invasive technique surface electrodes electrical energy to normalise the nervous stimulus This makes it an excellent complementary treatment to the activity of rehabilitation treatment Its effects are achieved by establishing several input nerve pathways corresponding to the bodys dermis through which the signals are intellectualised in time-space These signals are the basis for achieving normalisation of the nerve impulse by means of microcurrents
One of the disorders most frequently associated with ASD and which most affects the quality of life of the child and his or her family is sleep disorders it is estimated that between 50 and 80 percent of children with ASD present this alteration and generally continue to suffer from it in adolescence and adulthood It has also been observed that there is a correlation between sleep problems and an increase in aggressive behaviour social and emotional deficits and deficits in activities of daily living which severely affects the child and his or her close family environment they become emotionally destabilised in a notorious way and this has a negative impact on their work and productive environment
The microcurrents generated by the non-invasive neuromodulation device introduce by means of a non-invasive technique surface electrodes electrical energy to normalise the nervous stimulus This makes it an excellent complementary treatment to the activity of rehabilitation treatment Its effects are achieved by establishing several input nerve pathways corresponding to the bodys dermis through which the signals are intellectualised in time-space These signals are the basis for achieving normalisation of the nerve impulse by means of microcurrents
Detailed Description:
The main objective will be to test the influence of surface neuromodulation applied NESA on sleep disturbances in children with Autism Spectrum Disorders and how this is related to disruptive behaviours and quality of life in the family environment
It is estimated to take 8 months from the design management and development of the project and does not have sources of funding
It is estimated to take 8 months from the design management and development of the project and does not have sources of funding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None