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

Primary Purpose

"Attention Deficit Hyperactivity Disorder"

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Ritalin

Placebo

About this trial

This is an interventional diagnostic trial for "Attention Deficit Hyperactivity Disorder" focused on measuring EEG Attention Deficit / Hyperactivity Disorder (ADHD) Ritalin machine learning

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hadassah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ritalin

Placebo

Arm Description

Ritalin treatment at different doses

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01962181

First Posted

September 15, 2013

Last Updated

October 10, 2013

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01962181

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

"Attention Deficit Hyperactivity Disorder"

Keywords

EEG Attention Deficit / Hyperactivity Disorder (ADHD) Ritalin machine learning

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ritalin

Arm Type

Active Comparator

Arm Description

Ritalin treatment at different doses

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ritalin

Intervention Description

Patients with ADHD and healthy subjects will be examined under Ritalin or placebo

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renana Eitan, MD

renanaeitan@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shahar Arzy, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renana Eitan, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91000

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renana Eitan, MD

renanaeitan@gmail.com

First Name & Middle Initial & Last Name & Degree

Renana Eitan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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