Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- "Attention Deficit Hyperactivity Disorder"
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Intervention group will be compared to historical controls.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 12 years
- Gender
- Both males and females
Description
All participants enrolled in this study will not be taking medications for attention deficit hyperactivity disorder (ADHD), including stimulants, for the duration of the study. Participants who are taking ADHD medications prior to Day 0 must have been stable off of medications for at least 30 days p...
All participants enrolled in this study will not be taking medications for attention deficit hyperactivity disorder (ADHD), including stimulants, for the duration of the study. Participants who are taking ADHD medications prior to Day 0 must have been stable off of medications for at least 30 days per parent report, or washout of medications at a Screening visit 3 - 7 days prior to Day 0. At Baseline / Day 0, all eligible participants will complete both resting-state electroencephalogram (EEG) and a perceptual discrimination task (PDT)-locked EEG. All participants will then play AKL-T01 for approximately 25 minutes per day, 5 days per week, for 4 weeks at home. At Follow-up / Day 28, participants will repeat both resting-state and PDT-locked EEG.
Tracking Information
- NCT #
- NCT03844269
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elysa J Marco, MD Cortica Healthcare
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