tES With Random Noise Stimulation Applied to Children With Brain Injury (BrainInjury)

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fernando Vargas Torcal, PhD
  • Phone Number: +34 966 66 15 29
  • Email: vargas_fer@gva.es

Study Locations

    • Alicante
      • Elche, Alicante, Spain, 03201
        • Fundación Salud Infantil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Description

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 ...

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Receive treatment with physiotherapy
Standard of care physiotherapy aimed to the motor impairment the subject presents
Experimental: Experimental or tRNS Group
Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)
Standard of care physiotherapy aimed to the motor impairment the subject presents
A special Helmet supply weak electrical currents in the head
Other Names:
  • tRNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
Time Frame: Up to five months
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
Time Frame: up to five months
Changes in Power in EEG over different electrodes
up to five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Moises Aguilar, PhD, Fundación Española para el Desarrollo de la Neurometria (Brainmech)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

September 13, 2021

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

November 21, 2015

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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