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Clinical Trials/NCT01962181
NCT01962181
Unknown
Not Applicable

Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment

Hadassah Medical Organization1 site in 1 country40 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Ritalin
Conditions
"Attention Deficit Hyperactivity Disorder"
Sponsor
Hadassah Medical Organization
Enrollment
40
Locations
1
Primary Endpoint
Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.
Last Updated
12 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Ritalin

Ritalin treatment at different doses

Intervention: Ritalin

Placebo

Two meetings, one of which will be given a placebo and the other will be given a low dose of Ritalin, randomly.

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Study Sites (1)

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