search
Back to results

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

Primary Purpose

Brain Injury, Motor Skills Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcranial Random Noise Stimulation
Physiotherapy
Sponsored by
Spanish Foundation for Neurometrics Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring QEEG, ERP, tRNS, Brain injury, Motor Impairment, Transcranial Brain non-invasive stimulation, electroencephalogram

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept 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 ...

Sites / Locations

  • Fundación Salud Infantil

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Experimental or tRNS Group

Arm Description

Receive treatment with physiotherapy

Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)

Outcomes

Primary Outcome Measures

Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
Motor Functionality Scale

Secondary Outcome Measures

Differences in Power Fast Fourier Transformation before and after intervention
Changes in Power in EEG over different electrodes

Full Information

First Posted
November 21, 2015
Last Updated
April 10, 2023
Sponsor
Spanish Foundation for Neurometrics Development
Collaborators
Universidad Católica San Antonio de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT02656433
Brief Title
tES With Random Noise Stimulation Applied to Children With Brain Injury
Acronym
BrainInjury
Official Title
Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Foundation for Neurometrics Development
Collaborators
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Motor Skills Disorders
Keywords
QEEG, ERP, tRNS, Brain injury, Motor Impairment, Transcranial Brain non-invasive stimulation, electroencephalogram

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Receive treatment with physiotherapy
Arm Title
Experimental or tRNS Group
Arm Type
Experimental
Arm Description
Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)
Intervention Type
Device
Intervention Name(s)
Transcranial Random Noise Stimulation
Other Intervention Name(s)
tRNS
Intervention Description
A special Helmet supply weak electrical currents in the head
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Standard of care physiotherapy aimed to the motor impairment the subject presents
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
Description
Motor Functionality Scale
Time Frame
Up to five months
Secondary Outcome Measure Information:
Title
Differences in Power Fast Fourier Transformation before and after intervention
Description
Changes in Power in EEG over different electrodes
Time Frame
up to five months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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 ...
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moises Aguilar, PhD
Organizational Affiliation
Fundación Española para el Desarrollo de la Neurometria (Brainmech)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Salud Infantil
City
Elche
State/Province
Alicante
ZIP/Postal Code
03201
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25337347
Citation
Bashir S, Yoo WK. Cheap Technology Like Transcrinal Direct Current Stimulation (tDCS) Could Help in Stroke Rehabilitation in South Asia. Basic Clin Neurosci. 2013 Summer;4(3):188-9. No abstract available.
Results Reference
background
PubMed Identifier
21343407
Citation
Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
Results Reference
background
PubMed Identifier
20870863
Citation
Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, Hallett M. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1105-11. doi: 10.1136/jnnp.2009.202556. Erratum In: J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):354.
Results Reference
result
PubMed Identifier
16809569
Citation
Fregni F, Boggio PS, Valle AC, Rocha RR, Duarte J, Ferreira MJ, Wagner T, Fecteau S, Rigonatti SP, Riberto M, Freedman SD, Pascual-Leone A. A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. Stroke. 2006 Aug;37(8):2115-22. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29.
Results Reference
result
PubMed Identifier
24391599
Citation
Vanneste S, Fregni F, De Ridder D. Head-to-Head Comparison of Transcranial Random Noise Stimulation, Transcranial AC Stimulation, and Transcranial DC Stimulation for Tinnitus. Front Psychiatry. 2013 Dec 18;4:158. doi: 10.3389/fpsyt.2013.00158. eCollection 2013.
Results Reference
result
PubMed Identifier
17068786
Citation
Fregni F, Otachi PT, Do Valle A, Boggio PS, Thut G, Rigonatti SP, Pascual-Leone A, Valente KD. A randomized clinical trial of repetitive transcranial magnetic stimulation in patients with refractory epilepsy. Ann Neurol. 2006 Oct;60(4):447-55. doi: 10.1002/ana.20950.
Results Reference
result
PubMed Identifier
22031888
Citation
Fertonani A, Pirulli C, Miniussi C. Random noise stimulation improves neuroplasticity in perceptual learning. J Neurosci. 2011 Oct 26;31(43):15416-23. doi: 10.1523/JNEUROSCI.2002-11.2011.
Results Reference
result
PubMed Identifier
16270180
Citation
Ilyukhina VA, Kozhushko NY, Matveev YK, Ponomareva EA, Chernysheva EM, Shaptilei MA. Transcranial micropolarization in the combined therapy of speech and general psychomotor retardation in children of late preschool age. Neurosci Behav Physiol. 2005 Nov;35(9):969-76. doi: 10.1007/s11055-005-0153-7.
Results Reference
result
PubMed Identifier
23630476
Citation
McCleery JP, Elliott NA, Sampanis DS, Stefanidou CA. Motor development and motor resonance difficulties in autism: relevance to early intervention for language and communication skills. Front Integr Neurosci. 2013 Apr 24;7:30. doi: 10.3389/fnint.2013.00030. eCollection 2013.
Results Reference
result
PubMed Identifier
20522259
Citation
Mueller A, Candrian G, Kropotov JD, Ponomarev VA, Baschera GM. Classification of ADHD patients on the basis of independent ERP components using a machine learning system. Nonlinear Biomed Phys. 2010 Jun 3;4 Suppl 1(Suppl 1):S1. doi: 10.1186/1753-4631-4-S1-S1.
Results Reference
result
PubMed Identifier
21771289
Citation
Mueller A, Candrian G, Grane VA, Kropotov JD, Ponomarev VA, Baschera GM. Discriminating between ADHD adults and controls using independent ERP components and a support vector machine: a validation study. Nonlinear Biomed Phys. 2011 Jul 19;5:5. doi: 10.1186/1753-4631-5-5.
Results Reference
result
PubMed Identifier
10990547
Citation
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Results Reference
result
PubMed Identifier
11723286
Citation
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
Results Reference
result
PubMed Identifier
12686268
Citation
Nitsche MA, Nitsche MS, Klein CC, Tergau F, Rothwell JC, Paulus W. Level of action of cathodal DC polarisation induced inhibition of the human motor cortex. Clin Neurophysiol. 2003 Apr;114(4):600-4. doi: 10.1016/s1388-2457(02)00412-1.
Results Reference
result
PubMed Identifier
17251360
Citation
Nitsche MA, Doemkes S, Karakose T, Antal A, Liebetanz D, Lang N, Tergau F, Paulus W. Shaping the effects of transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2007 Apr;97(4):3109-17. doi: 10.1152/jn.01312.2006. Epub 2007 Jan 24.
Results Reference
result
PubMed Identifier
20633386
Citation
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Results Reference
result
PubMed Identifier
21819181
Citation
Paulus W. Transcranial electrical stimulation (tES - tDCS; tRNS, tACS) methods. Neuropsychol Rehabil. 2011 Oct;21(5):602-17. doi: 10.1080/09602011.2011.557292. Epub 2011 Aug 5.
Results Reference
result
PubMed Identifier
9694210
Citation
Priori A, Berardelli A, Rona S, Accornero N, Manfredi M. Polarization of the human motor cortex through the scalp. Neuroreport. 1998 Jul 13;9(10):2257-60. doi: 10.1097/00001756-199807130-00020.
Results Reference
result
PubMed Identifier
17452283
Citation
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Results Reference
result
PubMed Identifier
19833552
Citation
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
Results Reference
result
PubMed Identifier
19064743
Citation
Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.
Results Reference
result
PubMed Identifier
21631313
Citation
Schneider HD, Hopp JP. The use of the Bilingual Aphasia Test for assessment and transcranial direct current stimulation to modulate language acquisition in minimally verbal children with autism. Clin Linguist Phon. 2011 Jun;25(6-7):640-54. doi: 10.3109/02699206.2011.570852. Epub 2011 Jun 1.
Results Reference
result
PubMed Identifier
21072168
Citation
Zaehle T, Rach S, Herrmann CS. Transcranial alternating current stimulation enhances individual alpha activity in human EEG. PLoS One. 2010 Nov 1;5(11):e13766. doi: 10.1371/journal.pone.0013766.
Results Reference
result

Learn more about this trial

tES With Random Noise Stimulation Applied to Children With Brain Injury

We'll reach out to this number within 24 hrs