A jolt to the brain may unlock words: testing tDCS for language in down syndrome
NCT ID NCT07044804
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a gentle electrical current applied to the brain, called transcranial direct current stimulation (tDCS), can boost language skills in adolescents and young adults with Down syndrome when paired with speech therapy. Thirty-six participants aged 12 to 21 will receive either active tDCS (anodal or cathodal) or a sham version over 10 sessions. The goal is to see if the stimulation improves expressive vocabulary and other language abilities, and whether any benefits last for three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcranial direct current stimulation (tDCS) applied to the left inferior frontal gyrus, combined with speech and language training
- What this could lead to
- If effective, this approach could offer a new, non-invasive rehabilitation strategy to improve language abilities in adolescents and young adults with Down syndrome.
- What could go wrong
- This is a small, early proof-of-concept study with only 36 participants. It is unclear whether tDCS will produce lasting benefits, and individual responses may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bambino Gesù Children's Hospital, IRCCS
RECRUITINGRome, 00165, Italy
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Other studies related to the condition(s) this trial covers.
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