NCT02625805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 16, 2017

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

December 7, 2015

Last Update Submit

June 15, 2017

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Participants diagnosed with ADD/ADHD

EXPERIMENTAL

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

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

Healthy participants

EXPERIMENTAL

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

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

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.

Healthy participantsParticipants diagnosed with ADD/ADHD
EEG monitoring (EPOC by Emotiv)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.

Healthy participantsParticipants diagnosed with ADD/ADHD
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.

Healthy participantsParticipants diagnosed with ADD/ADHD

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Hospital

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yuval Bloch, MD

    Shalvata Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 9, 2015

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

June 16, 2017

Record last verified: 2016-07

Locations

IL(1)