Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

NCT ID: NCT02625805

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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. .

Conditions

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ADHD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participants diagnosed with ADD/ADHD

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

Group Type EXPERIMENTAL

EEG monitoring (MindWave by NeuroSky)

Intervention Type 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)

Intervention Type 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

Intervention Type 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.

Healthy participants

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

Group Type EXPERIMENTAL

EEG monitoring (MindWave by NeuroSky)

Intervention Type 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)

Intervention Type 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

Intervention Type 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.

Interventions

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EEG monitoring (MindWave by NeuroSky)

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.

Intervention Type DEVICE

EEG monitoring (EPOC by Emotiv)

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.

Intervention Type DEVICE

Methylphenidate

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brainmarc Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuval Bloch, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Hospital

Locations

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Shalvata Hospital

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLD5

Identifier Type: -

Identifier Source: org_study_id

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