Electroencephalogram and Attention Deficit Hyperactivity Disorder Study

NCT ID: NCT02154321

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-09-15

Brief Summary

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The purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with Attention Deficit Hyperactivity Disorder (ADHD) relative to adult participants without ADHD using the technique electroencephalogram (EEG). Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of this study is to establish biological factors for determining the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD).

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Healthy Controls

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Attention Deficit Hyperactivity Disorder

This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires.

Electroencephalogram (EEG)

Intervention Type DEVICE

The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes.

Healthy Control

This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires.

Electroencephalogram (EEG)

Intervention Type DEVICE

The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes.

Interventions

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Electroencephalogram (EEG)

The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes.

Intervention Type DEVICE

Other Intervention Names

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ActiveTwo EEG System Manufacturer: BioSemi Supplier: Cortech Solutions BEU Number: 409917

Eligibility Criteria

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Inclusion Criteria

* Right-handedness


* Currently unmedicated adults with ADHD. To be given a full diagnosis of adult ADHD, the participant must have full Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) criteria: (1) described a chronic course of ADHD symptomatology from childhood to adulthood, and (2) endorsed a moderate or sever level of impairment attributed to the ADHD symptoms.

Exclusion Criteria

* Currently taking psychoative medications
* Any clinically significant neurological problem (e.g., tics, seizures, serious head injury)
* Alcohol or substance abuse (current or in the past 2 years)
* Any current Axis I psychiatric diagnosis (other than ADHD) as verified by clinical interview
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Chandra Sekhar Sripada

Chandra Sekhar Sripada, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chandra S Sripada, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Rachel Upjohn Building

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00081947

Identifier Type: -

Identifier Source: org_study_id