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

Brain-directed Treatment to Improve Language in Adolescents and Young Adults With Down Syndrome: the Efficacy of Transcranial Direct Current Stimulation Coupled With Linguistic Training.

This project will test whether short sessions of transcranial direct current stimulation (tDCS) to the left frontal language area, combined with speech practice, can improve language in Italian-speaking adolescents and young adults with Down syndrome.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 12 Years to 21 Years
• Sex: All
• Sponsor: Bambino Gesù Hospital and Research Institute (other)
• Locations: 1 site (Rome, Italy)
• Trial ID: NCT07044804 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Italian-speaking adolescents and young adults (12–21 years) with confirmed free trisomy 21, mental age ≥ 4 years, measurable speech intelligibility (ICS ≥ 3.5), and low scores on naming subtests.

Not a fit: Those with epilepsy, major psychiatric disorders, significant hearing or vision deficits, very low naming or imitation ability, or inability to attend repeated in-person visits are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, participants could have improved naming and speech intelligibility that persist beyond the training sessions.

How similar studies have performed: Previous small trials combining tDCS with cognitive or language training have reported modest benefits in adults and some pediatric samples, but applying cathodal protocols specifically in Down syndrome is largely novel and untested.

Eligibility criteria

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 this trial is running

Rome, Italy

• Bambino Gesù Children's Hospital, IRCCS — Rome, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Floriana Costanzo, PsyD, PhD

Conditions: Down Syndrome, Trisomy 21, tDCS, Non-invasive brain stimulation, Speech, Neuroplasticity, BDNF, neurofilament light chain