Electroencephalogram and Attention Deficit Hyperactivity Disorder Study

EEG and ADHD Study

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).

Study Overview

• Status: Withdrawn
• Conditions: Attention Deficit Hyperactivity Disorder; Healthy Controls
• Intervention / Treatment: Device: Electroencephalogram (EEG)

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-2700
      • Rachel Upjohn Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 adult participants will be recruited for this study: 50 adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls.

Description

Inclusion Criteria for all:

• Right-handedness

Inclusion Criteria for Attention Deficit Hyperactivity Disorder (ADHD) group:

• 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 for all:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.; Other Names: ActiveTwo EEG System; Manufacturer: BioSemi; Supplier: Cortech Solutions; BEU Number: 409917
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.	Device: 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.; Other Names: ActiveTwo EEG System; Manufacturer: BioSemi; Supplier: Cortech Solutions; BEU Number: 409917

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Wave Measurements	Measurement of electroencephalogram amplitude and coherence in alpha, gamma, and theta brain wave bands.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Default Network Signatures	Measurement of the brain's default network consisting of interconnected midline and lateral parietal regions involved in internally directed mentation.	two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of dependent measurements between Attention Deficit Hyperactivity Disorder and healthy controls	Comparison of dependent measures (i.e., computer tasks performed during electroencephalogram [EEG]: the Resting task and the Attention Control Task) between Attention Deficit Hyperactivity Disorder and healthy controls with independent sample t-tests.	two years

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Chandra S Sripada, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: HUM00081947