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

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ClinicalTrials.gov Identifier: NCT02656433
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Universidad Católica San Antonio de Murcia
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Brain Injury Motor Skills Disorders Device: Transcranial Random Noise Stimulation Other: Physiotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 13, 2017
Estimated Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Receive treatment with physiotherapy
Other: 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)
Device: Transcranial Random Noise Stimulation
A special Helmet supply weak electrical currents in the head
Other Name: tRNS

Other: Physiotherapy
Standard of care physiotherapy aimed to the motor impairment the subject presents




Primary Outcome Measures :
  1. Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale [ Time Frame: Up to five months ]
    Motor Functionality Scale


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ...

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656433


Contacts
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Contact: Moises Aguilar, PhD +34634589106 moises.aguilar@uchceu.es
Contact: Fernando Vargas Torcal, PhD +34 966 66 15 29 vargas_fer@gva.es

Locations
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Spain
Fundación Salud Infantil Recruiting
Elche, Alicante, Spain, 03201
Contact: Fernando Vargas Torcal, PhD    966 66 15 29    vargas_fer@gva.es   
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
Universidad Católica San Antonio de Murcia
Investigators
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Principal Investigator: Moises Aguilar, PhD Fundación Española para el Desarrollo de la Neurometria (Brainmech)

Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT02656433     History of Changes
Other Study ID Numbers: TRNS23062015
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spanish Foundation for Neurometrics Development:
QEEG
ERP
tRNS
Brain injury
Motor Impairment
Transcranial Brain non-invasive stimulation
electroencephalogram

Additional relevant MeSH terms:
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Brain Injuries
Motor Skills Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurodevelopmental Disorders
Mental Disorders