tES With Random Noise Stimulation Applied to Children With Brain Injury

Study Overview
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Brief Summary
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50 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.

Detailed Description
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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.

Official Title
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Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury

Conditions
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Brain Injury, Motor Skills Disorders

Intervention / Treatment
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* Device: Transcranial Random Noise Stimulation
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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 ...

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Receive treatment with physiotherapy | Other: Physiotherapy<br>* Standard of care physiotherapy aimed to the motor impairment the subject presents<br>|
| Experimental: Experimental or tRNS Group<br>Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS) | Device: Transcranial Random Noise Stimulation<br>* A special Helmet supply weak electrical currents in the head<br>* Other names: tRNS;Other: Physiotherapy<br>* Standard of care physiotherapy aimed to the motor impairment the subject presents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale | Motor Functionality Scale | Up to five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Power Fast Fourier Transformation before and after intervention | Changes in Power in EEG over different electrodes | up to five months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QEEG, ERP, tRNS, Brain injury, Motor Impairment, Transcranial Brain non-invasive stimulation, electroencephalogram