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

NCT02523105 | Completed

• 1 other identifier: 0010-15
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Participants diagnosed with depression.

OTHER

EEG monitoring and evaluation

Device: EEG monitoring

Healthy participants.

OTHER

EEG monitoring and evaluation

Device: EEG monitoring

Interventions

EEG monitoring DEVICE

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.

Healthy participants.; Participants diagnosed with depression.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Brief Symptom Inventory (BSI \< 2.3).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brainmarc Ltd.: lead

Study Sites (2)

Haemek medical center

Afula, 18341, Israel

Location

Shalvata Hospital

Hod HaSharon, Israel

Location

Related Links

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

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: October 9, 2016
• Study Completion: January 5, 2017
• Last Updated: April 26, 2018

Record last verified: 2016-07

Locations

IL (2)