Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

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

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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Device: EEG monitoring (MindWave by NeuroSky); Device: EEG monitoring (EPOC by Emotiv); Drug: Methylphenidate

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hod Hasharon, Israel
    • Shalvata Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants diagnosed with ADD/ADHD; EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration	Device: 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.; 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.; Drug: 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.
Experimental: Healthy participants; EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration	Device: 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.; 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.; Drug: 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.

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

Collaborators and Investigators

• Sponsor: Brainmarc Ltd.
• Investigators: Principal Investigator: Yuval Bloch, MD, Shalvata Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: CLD5