Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

Brainmarc Ltd.30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

ADHD

Interventions

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

MethylphenidateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shalvata Hospital

Hod HaSharon, Israel

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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