Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

Study Overview
=================
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. .

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

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Device: EEG monitoring (MindWave by NeuroSky)
* Device: EEG monitoring (EPOC by Emotiv)
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants diagnosed with ADD/ADHD<br>EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration | Device: EEG monitoring (MindWave by NeuroSky)<br>* 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.<br>Device: EEG monitoring (EPOC by Emotiv)<br>* 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.<br>Drug: Methylphenidate<br>* Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.<br>|
| Experimental: Healthy participants<br>EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration | Device: EEG monitoring (MindWave by NeuroSky)<br>* 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.<br>Device: EEG monitoring (EPOC by Emotiv)<br>* 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.<br>Drug: Methylphenidate<br>* Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of brain electrical signal in Micro volt. | 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. | 2 weeks |