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New treatment option for Down Syndrome
Official title Non-Invasive Brain Stimulation to Improve Language in Down Syndrome.
ClinicalTrials.gov ID: NCT07044804
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Italian speakers participants of both genders with the presence of a free trisomy 21 documented by karyotyping
- Adolescents and young adults from 12 to 21 years old
- Mental age ≥ 4 years (as assessed by Leiter-3 at baseline)
- Scores \< 2 SD at the denomination subtest of BVL\_4-12
- Be comprehensible to closest relatives, at least in part, exhibiting consistent speech sounds mesured by Intelligibility in Context Scale (ICS)...
You likely can't join if
- The presence of any neurosensory deficits, such as hypoacusis or serious visual impairments
- The presence of epilepsy, familiarity with epilepsy and major psychopathological disorders
- Scores \< 10 points at the denomination subtest of BVL\_4-12
- Ability to verbally imitate less that 7 of 10 words during an imitation screening task
- Undergoing concomitant speech therapy or psychopharmacological therapy for cognitive or behavioral improvement.
See the full eligibility criteria
- Italian speakers participants of both genders with the presence of a free trisomy 21 documented by karyotyping
- Adolescents and young adults from 12 to 21 years old
- Mental age ≥ 4 years (as assessed by Leiter-3 at baseline)
- Scores \< 2 SD at the denomination subtest of BVL\_4-12
- 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
- Informed consent/absent from each patient and Informed consent from their caregivers.
- The presence of any neurosensory deficits, such as hypoacusis or serious visual impairments
- The presence of epilepsy, familiarity with epilepsy and major psychopathological disorders
- Scores \< 10 points at the denomination subtest of BVL\_4-12
- Ability to verbally imitate less that 7 of 10 words during an imitation screening task
- Undergoing concomitant speech therapy or psychopharmacological therapy for cognitive or behavioral improvement.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.