- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656433
tES With Random Noise Stimulation Applied to Children With Brain Injury (BrainInjury)
Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Moises Aguilar, PhD
- Phone Number: +34634589106
- Email: moises.aguilar@uchceu.es
Study Contact Backup
- Name: Fernando Vargas Torcal, PhD
- Phone Number: +34 966 66 15 29
- Email: vargas_fer@gva.es
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03201
- Fundación Salud Infantil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
Receive treatment with 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)
|
Standard of care physiotherapy aimed to the motor impairment the subject presents
A special Helmet supply weak electrical currents in the head
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
Time Frame: Up to five months
|
Motor Functionality Scale
|
Up to five months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Power Fast Fourier Transformation before and after intervention
Time Frame: up to five months
|
Changes in Power in EEG over different electrodes
|
up to five months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Moises Aguilar, PhD, Fundación Española para el Desarrollo de la Neurometria (Brainmech)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRNS23062015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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