Non-invasive brain stimulation to improve language in people with Down syndrome.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This proof-of-concept, double-blind, placebo-controlled trial applies transcranial direct current stimulation (tDCS) to the left inferior frontal gyrus (IFG)—using either anodal or cathodal protocols—combined with speech-language practice to try to improve naming and intelligibility in adolescents and young adults with Down syndrome. Participants are Italian-speaking individuals aged 12–21 with confirmed free trisomy 21 and defined speech and mental-age eligibility; they receive active or sham stimulation over multiple in-person sessions at a single pediatric research center. Outcome measures focus on standardized naming subtests and caregiver-rated speech intelligibility along with short-term maintenance assessments. The trial compares clinical change after combined tDCS-plus-training versus sham-plus-training to determine whether stimulation adds benefit to behavioral therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bambino Gesù Children's Hospital, IRCCS
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Floriana Costanzo, PsyD, PhD
• Email: floriana.costanzo@opbg.net
• Phone: +390668597091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.