tES With Random Noise Stimulation Applied to Children With Brain Injury
This trial is active, not recruiting.
|Conditions||brain injury, motor skills disorders|
|Treatments||transcranial random noise stimulation, physiotherapy|
|Sponsor||Spanish Foundation for Neurometrics Development|
|Collaborator||Universidad Católica San Antonio de Murcia|
|Start date||June 2015|
|End date||May 2016|
|Trial size||30 participants|
|Trial identifier||NCT02656433, TRNS23062015|
30 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50% females will participate in an interventional study in two groups: placebo and experimental group.
Placebo group will only receive traditional treatment with physiotherapy and the Experimental or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, investigator)|
Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
time frame: Up to five months
Differences in Power Fast Fourier Transformation before and after intervention
time frame: up to five months
Male or female participants from 3 years up to 7 years old.
Inclusion Criteria: - Patients between 3 and 7 years. - Meet criteria for Congenital or Acquired Brain Injury . - Patients who have been diagnosed at least 1 year before inclusion in the study. Exclusion Criteria: - Acute visual or hearing loss. - Other neurological disorders: migraine, epilepsy, tuberous sclerosis - Other neurodevelopmental disorders like ASD, ADHD, PDD, etc ...
|Official title||Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury|
|Principal investigator||Moises Aguilar, PhD|
|Description||In this Interventional Study with Double Blind Assignment to Placebo and Experimental Group, Gross Motor Function Measure (GMFM) and Neurophysiological are the parameters measured with EEG amplifier before and after 30 sessions. Work hypothesis is that the tRNS Group will present better motor functionality after 30 sessions of 30 minutes of duration of electrical brain stimulation administered during physiotherapy exercises 2 days per week than the Group that only receives treatment with physiotherapy during 30 minutes 2 days per week without tRNS.|
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