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WithdrawnNCT02154321Updated Nov 7, 2017

Electroencephalogram and Attention Deficit Hyperactivity Disorder Study

An observational study in Attention Deficit Hyperactivity Disorder and Healthy Controls, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by University of Michigan · Observational

Why this study was withdrawn
Funding and resource restrictions.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years to 35 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
  • Healthy Controls
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

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Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • 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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceElectroencephalogram (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.

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

06

What researchers measure

Primary outcomes

  1. Brain Wave Measurements

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

    Time frame: Two years

Secondary outcomes

  1. Default Network Signatures

    Measurement of the brain's default network consisting of interconnected midline and lateral parietal regions involved in internally directed mentation.

    Time frame: two years

Other outcomes

  1. 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.

    Time frame: two years

07

Study locations

1 site
  • Rachel Upjohn Building
    Ann Arbor, Michigan 48109-2700, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02154321
Lead sponsor
University of Michigan
Responsible party
Chandra Sekhar Sripada (Chandra Sekhar Sripada, MD, PhD, University of Michigan) — Principal investigator
First posted
Jun 3, 2014
Start date
Feb 2014
Primary completion
Sep 15, 2017
Completion
Sep 15, 2017
Last update
Nov 7, 2017

Study contacts

Chandra S Sripada, MD, PhD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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