Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Device: EEG monitoring (MindWave by NeuroSky); Device: EEG monitoring (EPOC by Emotiv); Drug: Methylphenidate

• Registration Number: NCT02625805
• Lead Sponsor: Brainmarc Ltd.

Brief Summary

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

Detailed Description

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. .

Study Timeline

• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-09
• Study Start: 2016-04
• Status Verified: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy participants	EEG monitoring (MindWave by NeuroSky)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration
Participants diagnosed with ADD/ADHD	EEG monitoring (MindWave by NeuroSky)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration
Participants diagnosed with ADD/ADHD	EEG monitoring (EPOC by Emotiv)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration
Healthy participants	EEG monitoring (EPOC by Emotiv)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration
Participants diagnosed with ADD/ADHD	Methylphenidate	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration
Healthy participants	Methylphenidate	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

Primary Outcome Measures

Name	Time	Method
Measurements of brain electrical signal in Micro volt.	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.

Trial Locations

Locations (1)

Shalvata Hospital; 🇮🇱 Hod Hasharon, Israel