tES With Random Noise Stimulation Applied to Children With Brain Injury

Not Applicable

Completed

• Conditions: Brain Injury; Motor Skills Disorders
• Interventions: Other: Physiotherapy; Device: Transcranial Random Noise Stimulation

• Registration Number: NCT02656433
• Lead Sponsor: Spanish Foundation for Neurometrics Development

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.

Study Timeline

• Study First Submitted: 2015-11-21
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-15
• Study Start: 2017-03-01
• Primary Completion: 2021-09-13
• Study Completion: 2023-01-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Physiotherapy	Receive treatment with physiotherapy
Experimental or tRNS Group	Physiotherapy	Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)
Experimental or tRNS Group	Transcranial Random Noise Stimulation	Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New Remedies; 🇬🇧 Liverpool, Merseyside, United Kingdom