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

Transcranial Direct Current Stimulation associated (tDCS) with Prompts for Restructuring Oral Muscle Phonetic Targets (PROMPT) in Apraxia of Speech in young people with Trisomy 21 - tDCS-PROMPT in CAS of T21: transcranial Direct Current Stimulation - Prompts for Restructuring Oral Muscle Phonetic Targets in Childhood Apraxia of Speech of Trisomy of 21

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-5435x9
Enrollment
Unknown
Registered
2020-02-19
Start date
2020-03-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apraxia

Interventions

The experimental group will be composed by 16 young T21 that will underwent to five double tDCS (2 mA, 35 cm2, 13:20:13 schedule) sessions, being anode over the Broca’s area in the left hemisphere and
Device
Other

Sponsors

Universidade Federal do Espírito Santo
Lead Sponsor
Ester Miyuki Nakamura Palacios
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Examine the activation (current density) in brain regions of interest using electrophysiological records (electroencephalography) of event-related potentials using a 30-channel wireless system operated by a lithium battery and with dry electrodes (Quick-30, Cognionics Inc., San Diego, USA) and later post-processed with BrainVision Analyzer 2.0 Professional software (BrainProducts Ltd, Munich, Germany) before, 24 hours and 30 days after intervention.;Magnetic Resonance Imaging Examination using a 1.5 Tesla Philips Magnetic Resonance Imager, Achieva model, with a specific skull coil, SENSE Head Coil model, 8 channels, before and 30 days after intervention.;Evaluate the intonation curves obtained by means of a spectrogram in the emission of an affirmative phrase such as "the beautiful girl is dancing" which will also be processed by the PRAAT program before, 24 hours and 30 days after the intervention.;To evaluate the pause marker index (PMI) between words defined as any pause of at least 150 ms in which there is no speech, considered a diagnostic marker to discriminate speech apraxia in childhood from speech delay and other subtypes of motor speech disorders before, 24 hours and 30 days after intervention.;Evaluate the scores of the social communication scale applied to parents and / or caregivers by applying an instrument developed to assess communication in children before, 24 hours and 30 days after intervention.

Countries

Brazil

Contacts

Public ContactEster Nakamura Palacios

Universidade Federal do Espírito Santo

emnpalacios@gmail.com+55 027 988462552

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026