Activity and attention disorders
Conditions
Interventions
3. sham-Direct Current Electrical Stimulation + psychostimulant
This is a randomized, double-blind, four-arm pilot clinical study. A total of 156 volunteers who meet the eligibility criteria will be randomized in a stratified manner (to better distribute the ADHD
2. Direct Current Electrical Stimulation + placebo
4. sham-Direct Current Electrical Stimulation + placebo). Neither the researcher who will assess the outcome nor the participants will be aware of which group each participant belongs to. To mask the
Group 2: 39 participants will undergo 20 daily sessions (Monday through Friday for 4 weeks) of Direct Current Electrical Stimulation lasting 20 minutes, with a continuous electrical current of 2mA, as
Group 3: 39 participants will undergo 20 daily sessions (Monday to Friday for 4 weeks) of sham-Direct Current Electrical Stimulation lasting 20 minutes, with continuous electrical current of 2mA, asso
Group 4 (control): 39 participants will undergo 20 daily sessions (Monday to Friday for 4 weeks) of sham-D
D02.092.471.683.152.110.200.500
Sponsors
Universidade Estadual do Sudoeste da Bahia
Clínica Quality
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Volunteers aged between 18 and 50 years; both sexes; diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) confirmed by a specialist through clinical evaluation; if previously diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), not using psychostimulant medication in the last 30 days; participants must be available for daily sessions of Direct Current Electrical Stimulation
Exclusion criteria
Exclusion criteria: Severe depression; Moderate to severe anxiety; Bipolar disorder with an episode of mania or depression in the last year; Schizophrenia or other psychotic disorder; Autism Spectrum Disorder; positive screening for substance use (alcohol, tobacco and other psychoactive substances); severe neurological and organic comorbidities (seizures, neoplasms, previous neurosurgery); carriers of cochlear implants or other metal implants; pregnant women or recent intention to become pregnant; family history of sudden death before age 50
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a statistical difference between the groups regarding the cognitive domains evaluated (attention, hyperactivity, impulsivity, emotional aspects and self-regulation of attention/motivation/action) using a validated scale (Scale for Attention Deficit Hyperactivity Disorder for adults and adolescents - ETDAH-AD), applied at the beginning and at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the safety of Direct Current Electrical Stimulation (tDCS) in groups associated or not with psychostimulants | — |
Countries
Brazil
Contacts
Public ContactJefferson Pires
Universidade Estadual do Sudoeste da Bahia
Outcome results
None listed