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Brain electrical stimulation associated with speech therapy in speech apraxia in young people with Trisomy 21 (Down Syndrome)

Phase 2
Conditions
Apraxia
R48.2
Registration Number
RBR-5435x9
Lead Sponsor
niversidade Federal do Espírito Santo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

They have to present clinical and / or genetic diagnosis of Trisomy 21 and meet criteria for intellectual disability (DSM-5) or intellectual development disorder (equivalent name found in ICD 11), and are classified according to the severity as mild (F70), moderate (F71), severe (F72), and profound (F73) according to ICD 10; they have to meet criteria for communication disorders (DSM-5), specifically speech sound disorder (F80.0); they should be clinically fit for the treatment proposed in the study and should therefore not present past or current illnesses that may be aggravated during treatment; they should also not have abnormalities in the laboratory tests, which may suggest a deterioration of their physical condition during the participation in the study; they should be able to understand the Portuguese language.

Exclusion Criteria

It should not be included young people diagnosed with other associated mental disorders such as attention deficit hyperactivity disorder (ADHD), depressive and bipolar disorders, anxiety disorders, autistic spectrum disorder, stereotypic movement (with or without self-injurious behavior), impulsive disorders, and major neurocognitive disorders;
those who have any metal in their brain or skull (splinters, fragments, pins, etc.) except for titanium, history of epilepsy, severe head injury, cochlear implant, cardiac pacemaker or intracardiac metal lines, should also not be included because of restrictions on the noninvasive brain stimulation technique; they will not be included due to MRI restrictions if they are carrying metal implant such as: heart valve, plate, pin, screw, stent, brain aneurysm clip, body shrapnel, piercing, metal prosthesis, orthodontic appliance, electronic implants such as cardiac pacemakers, neurostimulators, cochlear implants, claustrophobic patients and those with permanent makeup or tattooing done in the last three months.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assessement of the voice onset time (VOT, interval between the release of a plosive consonant and the start of vocal fold vibration) in milliseconds using acoustic analysis through the PRAAT program (available free at www.praat.org) before, 24 hours and 30 days after the intervention.
Secondary Outcome Measures
NameTimeMethod
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