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

Spanish Foundation for Neurometrics Development

Status: Completed

Conditions: Brain Injury; Motor Skills Disorders

Treatments: Other: Physiotherapy; Device: Transcranial Random Noise Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02656433

TRNS23062015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No 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 ...

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Receive treatment with physiotherapy

Treatment:

Other: Physiotherapy

Experimental or tRNS Group

Experimental group

Description:

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

Treatment:

Device: Transcranial Random Noise Stimulation

Other: Physiotherapy