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Completed

NCT Number: NCT02625805

Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shalvata Hospital

Hod HaSharon, Israel

About this study

The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.

The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, aged 18 -45 years.
  • Able and willing to comply with all study requirements.

Diagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:

  • Adult ADHD Self-Report Scale (ASRS)
  • Wender-Utah Rating Scale
  • Positive And Negative Affect Schedule (PANAS)

Exclusion criteria

Diagnosed with Psychotic or bipolar disorder.

  • Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
  • A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
  • Cognitive impairment.
  • Hearing disorder and/or known ear drum impairment.

Treatment and study plan

EEG monitoring (MindWave by NeuroSky)

Device

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset.

EEG monitoring (EPOC by Emotiv)

Device

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.

Methylphenidate

Drug

Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.

Primary outcomes

  1. Measurements of brain electrical signal in Micro volt.

    Time frame: 2 weeks

    Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to ADHD state as evaluated by participants questionnaires, and computerized test.

Sponsors and collaborators

Lead sponsor

Brainmarc Ltd.

Industry

Registry information

Official study title

Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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