Electroencephalogram and Attention Deficit Hyperactivity Disorder Study

NCT02154321 | Withdrawn

• 1 other identifier: HUM00081947
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Attention Deficit Hyperactivity Disorder; Healthy Controls

Outcome Measures

Primary Outcomes (1)

• Brain Wave Measurements

  Measurement of electroencephalogram amplitude and coherence in alpha, gamma, and theta brain wave bands.

  Two years

Secondary Outcomes (1)

• Default Network Signatures

  two years

Other Outcomes (1)

• Comparison of dependent measurements between Attention Deficit Hyperactivity Disorder and healthy controls

  two years

Study Arms (2)

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)

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)

Interventions

Electroencephalogram (EEG) 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.

Also known as: ActiveTwo EEG System, Manufacturer: BioSemi, Supplier: Cortech Solutions, BEU Number: 409917

Attention Deficit Hyperactivity Disorder; Healthy Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Rachel Upjohn Building

Ann Arbor, Michigan, 48109-2700, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Chandra S Sripada, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chandra Sekhar Sripada, MD, PhD

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2014
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

US (1)