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Non-Invasive Brain Stimulation to Improve Language in Down Syndrome.

RecruitingNAAges 12 Years - 21 YearsAllFloriana Costanzo
NCT07044804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Down syndrome (DS) is associated with cognitive deficits, caused by alterations in neuroplasticity and synaptic transmission. Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), can modulate the brain's plasticity mechanisms and neurotransmitter balance. Anodal tDCS increases cortical excitability by depolarizing neurons, while cathodal tDCS decreases it through hyperpolarization. When combined with cognitive training, tDCS may produce faster and longer-lasting therapeutic effects. Although most of the neurorehabilitation studies have applied anodal excitatory stimulation, recent evidence suggests the potential cathodal inhibitory stimulation in neurodevelopmental disorders with alteration of synaptic transmission, as people with DS. Potentially both anodal and cathodal stimulation protocols could lead to positive clinical effects in DS. T

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Italian speakers participants of both genders with the presence of a free trisomy 21 documented by karyotyping 2. Adolescents and young adults from 12 to 21 years old 3. Mental age ≥ 4 years (as assessed by Leiter-3 at baseline) 4. Scores \< 2 SD at the denomination subtest of BVL\_4-12 5. Be comprehensible to closest relatives, at least in part, exhibiting consistent speech sounds mesured by Intelligibility in Context Scale (ICS): Italian (McLeod, Harrison, \& McCormack, 2012) with a cut-off of 3.5 6. Informed consent/absent from each patient and Informed consent from their caregivers. Exclusion Criteria: 1. The presence of any neurosensory deficits, such as hypoacusis or serious visual impairments 2. The presence of epilepsy, familiarity with epilepsy and major psychopathological disorders 3. Scores \< 10 points at the denomination subtest of BVL\_4-12 4. Ability to verbally imitate less that 7 of 10 words during an imitation screening task 5. Undergoing concomitant speech therapy or psychopharmacological therapy for cognitive or behavioral improvement.
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What it tests

  • Active Group (Active Anodal tDCS to the left IFG or Cathodal tDCS to the left IFG)
  • Sham Group
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Where

1 site
Bambino Gesù Children's Hospital, IRCCS
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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