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

Launched by FLORIANA COSTANZO · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help improve language skills in teenagers and young adults with Down syndrome. The treatment uses a gentle, non-invasive brain stimulation called transcranial direct current stimulation (tDCS) combined with speech and language training. This brain stimulation works by sending a very mild electrical current to specific areas of the brain to help improve how brain cells communicate. The study aims to see if this approach can help participants speak better and if the benefits last for at least three months after the treatment.

The study is looking for participants aged 12 to 21 years who speak Italian, have Down syndrome confirmed by genetic testing, and have certain basic language skills. Those interested will receive 10 sessions over two weeks, where they will get either one of two types of brain stimulation or a placebo (a “sham” treatment that does not have real stimulation) while doing speech exercises. The researchers will check participants’ language abilities, behavior, and brain activity before, right after, and three months following the treatment to see how well it works. If successful, this study could lead to new ways to support language development in people with Down syndrome.

Gender

ALL

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.