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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01962181
• Other study ID #: RE0379-HMO-STILL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2013
• Last updated: October 10, 2013
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2013
• Source: Hadassah Medical Organization
• Contact: Renana Eitan, MD
• Email: renanaeitan[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.	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.	2 years	No