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

NCT ID: NCT02523105

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-01-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participants diagnosed with depression.

EEG monitoring and evaluation

Group Type OTHER

EEG monitoring

Intervention Type 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.

EEG monitoring and evaluation

Group Type OTHER

EEG monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.


* 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).

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brainmarc Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuval Bloch, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Hospital

Locations

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Haemek medical center

Afula, , Israel

Site Status

Shalvata Hospital

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Related Links

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https://www.frontiersin.org/articles/10.3389/fpsyt.2017.00128/full

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

Other Identifiers

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0010-15

Identifier Type: -

Identifier Source: org_study_id

NCT02583724

Identifier Type: -

Identifier Source: nct_alias

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