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Impact of neuromodulation on cognitive functions altered in Attention Deficit Hyperactivity Disorder (ADHD)

Impact of High-Definition Transcranial Electrical Stimulation with Alternating Current on Executive Functions in individuals with Attention Deficit Hyperactivity Disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-328krjg
Enrollment
Unknown
Registered
2025-04-16
Start date
2025-10-01
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

Attention-deficit hyperactivity disorder, predominantly inattentive type

Interventions

A two-arm, double-blind, parallel-group study, with the primary outcome being the improvement in working memory task performance after four sessions of high-definition transcranial alternating current
E02.331.750

Sponsors

Campus Integrado de Manufatura e Tecnologia - CIMATEC / SENAI
Lead Sponsor
Campus Integrado de Manufatura e Tecnologia - CIMATEC / SENAI
Collaborator

Eligibility

Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Provision of Free and Informed Consent in writing, signed and dated; provision of the assent term in writing, signed and dated; individuals of both sexes; right-handed; aged 12-18 years; diagnosed with Attention Deficit Hiperativity Deficit (ADHD) according to DSM-V criteria; residing in Salvador and the metropolitan area; enrolled in regular school or who have already completed high school; and who have medical authorization to suspend the use of psycho-stimulant medication for 48 hours prior to the interventions and for an additional 5 days during the intervention period. Individuals of both sexes; aged 12-18 years; without a diagnosis of ADHD; residing in Salvador and the metropolitan area, enrolled in regular school or who have already completed high school.

Exclusion criteria

Exclusion criteria: Research participants who have been involved in clinical study protocols in the last 12 (twelve) months, unless the investigator deems there may be a direct benefit to them (CNS Resolution 251, dated August 7, 1997, item III, subitem J); alcohol and drug abuse (previous diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders – DSM-V); use of illegal drug; any clinical condition interpreted by the investigating physician as a risk for the participant’s inclusion in the study, presence of head injuries contraindicating the use of neuromodulation; use of pacemakers; cochlear implants, or metal plates in the head; brain tumors; cranial deformities; diagnosis of depression and/or anxiety disorders, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), in the last 6 months; diagnosis of bipolar disorder, schizophrenia, autism spectrum disorder, and other developmental disorders diagnosed according to DSM-V; diagnosis of epilepsy; pregnant individuals; diagnosis of ADHD only with hyperactive presentation; initiation of new psychotropic medications or changes in the dosage of usual medication in the last 3 months; ose of psycho-stimulants 48 hours before and during the intervention; Oral language disorders and cognitive disorders that hinder understanding of the study procedures and the necessary responses; individuals who have suffered acquired neurological disorders or have congenital neurological disorders that may interfere with understanding the study results: cerebrovascular accidents, encephalopathies; visual or auditory impairments that prevent effective use of Virtual Reality; Episodes of nausea and labyrinthitis that, even when treated, hinder the use of Virtual Reality; any condition that, in the opinion of the principal investigator, poses a risk to the research participant during their participation in the study

Design outcomes

Primary

MeasureTime frame
Improvements in the working memory task are expected after 4 sessions of high or low-frequency high-definition transcranial alternating current stimulation in the left dorsolateral prefrontal cortex or inferior parietal lobe in patients with ADHD

Secondary

MeasureTime frame
Improvements in inhibitory control (impulsivity) during a working memory task are expected in adolescents with ADHD in the short term (immediate) and medium term (30 days).

Countries

Brazil, Spain

Contacts

Public ContactCamila Guimarães

Serviço Nacional de Aprendizagem Industrial

camivnova@gmail.com+55 (71) 3462-9580

Outcome results

None listed

Source: REBEC (via WHO ICTRP)