An interventional study of Transcranial direct current stimulation (tDCS) in Developmental Coordination Disorder, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Basic science
This study investigates the effects of Transcranial Direct Current Stimulation (tDCS) on postural control of children with Developmental Coordination Disorder (DCD). All participants will receive four conditions of stimulation, in a crossover protocol: cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS.
Developmental Coordination Disorder (DCD) is a highly frequent neurodevelopmental disorder with negative impacts on children's motor repertoire, quality of life and general health. One of the main problems faced is the balance deficit, which although well characterized in this population, little is known about the etiological core of this impairment. The cerebellum appears to be a functionally impaired structure in DCD, but frontal motor areas are also involved. Transcranial Direct Current Stimulation (tDCS) is a noninvasive way of inducing local-specific polarity-dependent synaptic modulation. Cerebellar tDCS (CE-tDCS) is even more recent, with still unclear results on its effects on postural balance, with only one study in children, which requires us to better understand the type of stimulation necessary to induce balance improvement in children with DCD.
Thus, the investigators aimed to verify the effects of anodal tDCS over primary motor cortex (M1-atDCS) and CE-tDCS (anodic, cathodic and sham) on the balance of children with DCD, compared to children without DCD.
METHODS: Fifteen children with DCD (total MABC-2 and balance \<15%, with DCDQ positive / TL positive) and 15 children without DCD (MABC-2 total and balance ≥50% and DCDQ negative) will be assessed by platform stabilometry (PS) before and after receiving M1, cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS (crossover). They will be evaluated under conditions without proprioceptive manipulation (direct on PS) with open and closed eyes, and with proprioceptive manipulation (on foam surface) with open and closed eyes.
98 studies on the registry are indexed under Motor Skills Disorders; 26 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 71 interventional studies indexed under Motor Skills Disorders.
Browse Motor Skills Disorders studies →University of Sao Paulo General Hospital is the lead sponsor of 609 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes
Device: Transcranial direct current stimulation (tDCS)
tDCS applied over the cerebellum. Dose: 1mA, 20 minutes
Device: Transcranial direct current stimulation (tDCS)
tDCS applied over the cerebellum. Dose: 1mA, 20 minutes
Device: Transcranial direct current stimulation (tDCS)
tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON)
Device: Transcranial direct current stimulation (tDCS)
Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
Change from COP - AP axis
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters
Time frame: Baseline and Post-tDCS (immediately after tDCS)
Change from COP - ML axis
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters
Time frame: Baseline and Post-tDCS (immediately after tDCS)
Change from COP - area
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²)
Time frame: Baseline and Post-tDCS (immediately after tDCS)
Adverse effects
Adverse effects will be evaluated using structured questionnaire. Active collection uses a questionnaire with records of the duration (minutes or hours) and intensity (Numerical Rating Scale 0-10) of adverse symptoms reported by the patient. Complaints: Headache Scalp pain Tingling Itching Redness Burning sensations Sleepiness Trouble concentrating Nausea Mood change
Time frame: Immediately after tDCS
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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