This trial is active, not recruiting.

Conditions brain injury, motor skills disorders
Treatments transcranial random noise stimulation, physiotherapy
Sponsor Spanish Foundation for Neurometrics Development
Collaborator Universidad Católica San Antonio de Murcia
Start date June 2015
End date May 2016
Trial size 30 participants
Trial identifier NCT02656433, TRNS23062015


30 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
Receive treatment with physiotherapy
Standard of care physiotherapy aimed to the motor impairment the subject presents
Receive treatment with physiotherapy plus Transcranial Random Noise Stimulation (tRNS)
transcranial random noise stimulation tRNS
A special Helmet supply weak electrical currents in the head
Standard of care physiotherapy aimed to the motor impairment the subject presents

Primary Outcomes

Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
time frame: Up to five months

Secondary Outcomes

Differences in Power Fast Fourier Transformation before and after intervention
time frame: up to five months

Eligibility Criteria

Male or female participants from 3 years up to 7 years old.

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 ...

Additional Information

Official title Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury
Principal investigator Moises Aguilar, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spanish Foundation for Neurometrics Development.