Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment

Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.

This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: EEG monitoring

Detailed Description

The study will be conducted in two arms:

In arm I, participants diagnosed with depression. In arm II, healthy participants.

Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.

Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • 'Afula, Israel, 18341
    • HaEmek Medical Center
  • Hod Hasharon, Israel
    • Shalvata Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 -70 years (Adult, Senior)
• Able and willing to comply with all study requirements.

Additional Inclusion Criteria for Arm I

• Diagnosed with depression
• Being within 2 days of receiving pharmaceutical treatment for depression for the first

time or changing dose or changing type of current pharmaceutical treatment or addition to

drug of current pharmaceutical treatment.

Additional Inclusion Criteria for Arm II

Brief Symptom Inventory (BSI < 2.3).

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

• Diagnosed with Psychotic disorder.
• Diagnosed with Central Neurological disorder.
• A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse

or dependence.

• Hearing disorder and/or known ear drum impairment.
• High suicide risk as judged by the research team.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participants diagnosed with depression.; EEG monitoring and evaluation	Device: EEG monitoring; EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.
Other: Healthy participants.; EEG monitoring and evaluation	Device: EEG monitoring; EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.	Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.	12 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• A Pilot Study of Possible Easy-to-Use Electrophysiological Index for Early Detection of Antidepressive Treatment Non-Response

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): October 9, 2016
• Study Completion (Actual): January 5, 2017

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 0010-15