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Completed

NCT Number: NCT02656433

tES With Random Noise Stimulation Applied to Children With 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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Motor Skills Disorders Nervous System Diseases Neurodevelopmental Disorders Trauma, Nervous System Wounds and Injuries

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Remedies

Liverpool, Merseyside, L1 0AH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...

Treatment and study plan

transcranial random noise stimulation

Device

A special Helmet supply weak electrical currents in the head

Other names: tRNS

Physiotherapy

Other

Standard of care physiotherapy aimed to the motor impairment the subject presents

Primary outcomes

  1. Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale

    Time frame: Up to five months

    Motor Functionality Scale

Secondary outcomes

  1. Differences in Power Fast Fourier Transformation before and after intervention

    Time frame: up to five months

    Changes in Power in EEG over different electrodes

Sponsors and collaborators

Lead sponsor

Spanish Foundation for Neurometrics Development

Other

Collaborators

  • Universidad Católica San Antonio de Murcia

Registry information

Official study title

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

Acronym: BrainInjury

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Jan 15, 2016
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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