Electroencephalogram and Attention Deficit Hyperactivity Disorder Study

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

EEG and ADHD Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02154321
• Other study ID #: HUM00081947
• Status: Withdrawn
• Phase: N/A
• First received: May 30, 2014
• Last updated: November 3, 2017
• Start date: February 2014
• Est. completion date: September 15, 2017

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Healthy Controls
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
United States	Rachel Upjohn Building	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Brain Wave Measurements	Measurement of electroencephalogram amplitude and coherence in alpha, gamma, and theta brain wave bands.	Two years
Secondary	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