NCT02656433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

November 21, 2015

Last Update Submit

May 6, 2024

Conditions

Brain InjuryMotor Skills Disorders

Keywords

QEEGERPtRNSBrain injuryMotor ImpairmentTranscranial Brain non-invasive stimulationelectroencephalogram

Outcome Measures

Primary Outcomes (1)

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

    Motor Functionality Scale

    Up to five months

Secondary Outcomes (1)

  • Differences in Power Fast Fourier Transformation before and after intervention

    up to five months

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Receive treatment with physiotherapy

Other: Physiotherapy

Experimental or tRNS Group

EXPERIMENTAL

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

Device: Transcranial Random Noise StimulationOther: Physiotherapy

Interventions

Transcranial Random Noise StimulationDEVICE

A special Helmet supply weak electrical currents in the head

Also known as: tRNS
Experimental or tRNS Group
PhysiotherapyOTHER

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

Experimental or tRNS GroupPlacebo Group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients between 3 and 7 years.
  • Meet criteria for Congenital or Acquired Brain Injury .

You may not qualify if:

  • Acute visual or hearing loss.
  • Other neurological disorders: migraine, epilepsy, tuberous sclerosis
  • Other neurodevelopmental disorders like ASD, ADHD, PDD, etc ...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Remedies

Liverpool, Merseyside, L1 0AH, United Kingdom

Location

Related Publications (23)

  • 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.

    PMID: 25337347BACKGROUND

  • Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.

    PMID: 21343407BACKGROUND

  • 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.

    PMID: 20870863RESULT

  • 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.

    PMID: 16809569RESULT

  • 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.

    PMID: 24391599RESULT

  • 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.

    PMID: 17068786RESULT

  • 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.

    PMID: 22031888RESULT

  • 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.

    PMID: 16270180RESULT

  • 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.

    PMID: 23630476RESULT

  • 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.

    PMID: 20522259RESULT

  • 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.

    PMID: 21771289RESULT

  • 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.

    PMID: 10990547RESULT

  • 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.

    PMID: 11723286RESULT

  • 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.

    PMID: 12686268RESULT

  • 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.

    PMID: 17251360RESULT

  • 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.

    PMID: 20633386RESULT

  • 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.

    PMID: 21819181RESULT

  • 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.

    PMID: 9694210RESULT

  • 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.

    PMID: 17452283RESULT

  • 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.

    PMID: 19833552RESULT

  • 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.

    PMID: 19064743RESULT

  • 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.

    PMID: 21631313RESULT

  • 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.

    PMID: 21072168RESULT

Related Links

MeSH Terms

Conditions

Brain InjuriesMotor Skills Disorders

Interventions

Transcranial Direct Current StimulationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesRehabilitation

Study Officials

  • Moises Aguilar Domingo, PhD

    Fundación Española para el Desarrollo de la Neurometria (Brainmech)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2015

First Posted

January 15, 2016

Study Start

March 1, 2017

Primary Completion

September 13, 2021

Study Completion

January 31, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

GB(1)