tES With Random Noise Stimulation Applied to Children With Brain Injury

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02656433

Acronym

BrainInjury

Enrollment

Registered

2016-01-15

Start date

2017-03-01

Completion date

2023-01-31

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Motor Skills Disorders

Keywords

QEEG, ERP, tRNS, Brain injury, Motor Impairment, Transcranial Brain non-invasive stimulation, electroencephalogram

Brief summary

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

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.

Interventions

DEVICETranscranial Random Noise Stimulation

A special Helmet supply weak electrical currents in the head

OTHERPhysiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

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 ...

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026