Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625805
• Other study ID #: CLD5
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: June 15, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: Brainmarc Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Shalvata Hospital	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Brainmarc Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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