Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

Brainmarc

Status: Completed

Conditions: ADHD

Treatments: Device: EEG monitoring (EPOC by Emotiv); Drug: Methylphenidate; Device: EEG monitoring (MindWave by NeuroSky)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02625805

CLD5

Details and patient eligibility

About

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

Full 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. .

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Participants diagnosed with ADD/ADHD

Experimental group

Description:

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

Treatment:

Device: EEG monitoring (MindWave by NeuroSky)

Drug: Methylphenidate

Device: EEG monitoring (EPOC by Emotiv)

Healthy participants

Experimental group

Description:

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

Treatment:

Device: EEG monitoring (MindWave by NeuroSky)

Drug: Methylphenidate

Device: EEG monitoring (EPOC by Emotiv)