Clinical Trial: tES With Random Noise Stimulation Applied to Children With Brain Injury

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:

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.

Sponsor: Spanish Foundation for Neurometrics Development

Current Primary Outcome: Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale [ Time Frame: Up to five months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Differences in Power Fast Fourier Transformation before and after intervention [ Time Frame: up to five months ]

Original Secondary Outcome: Same as current

Information By: Spanish Foundation for Neurometrics Development

Dates:
Date Received: November 21, 2015
Date Started: June 2015
Date Completion: June 2016
Last Updated: April 21, 2016
Last Verified: April 2016