Identifying Characteristic Signature of Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment

Overview

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment.

Full Title of Study: “Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2015

Detailed Description

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment. All subjects will undergo 1-4 EEG sessions. In each session we will use a different dose of Ritalin or placebo. A detailed neuropsychological tests will be done during the EEG recording. A powerful machine-learning techniques will be used in order to find a specific signature of ADHD and Ritalin treatment in the EEG recording.

Interventions

  • Drug: Ritalin
    • Patients with ADHD and healthy subjects will be examined under Ritalin or placebo
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: Ritalin
    • Ritalin treatment at different doses
  • Placebo Comparator: Placebo
    • Two meetings, one of which will be given a placebo and the other will be given a low dose of Ritalin, randomly.

Clinical Trial Outcome Measures

Primary Measures

  • Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.
    • Time Frame: 2 years
    • The primary outcome measure is the difference in the analysis of EEG recording (for example, resting oscillation activity and Event-related-Potentials) in Attention Deficit / Hyperactivity Disorder (ADHD) vs. healthy subjects.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy subjects, aged 18-50 years. – Subjects aged 18-50 years diagnosed with ADHD and treated with Ritalin regularly (at least once a week). Exclusion Criteria:

  • Patients previously diagnosed as suffering from a brain disease except for ADHD. – Patients after traumatic head injury. – Patients who are unable to express their consent to participate in the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renana Eitan, MD, Principal Investigator, Hadassah Medical Organization
  • Overall Contact(s)
    • Renana Eitan, MD, renanaeitan@gmail.com

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