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

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

EEG monitoring

About this trial

This is an interventional diagnostic trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Haemek medical center
Shalvata Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Participants diagnosed with depression.

Healthy participants.

Arm Description

EEG monitoring and evaluation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02523105

First Posted

August 10, 2015

Last Updated

April 25, 2018

Sponsor

Brainmarc Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02523105

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

October 9, 2016 (Actual)

Study Completion Date

January 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brainmarc Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants diagnosed with depression.

Arm Type

Other

Arm Description

EEG monitoring and evaluation

Arm Title

Healthy participants.

Arm Type

Other

Arm Description

EEG monitoring and evaluation

Intervention Type

Device

Intervention Name(s)

EEG monitoring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.

Description

Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuval Bloch, MD

Organizational Affiliation

Shalvata Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haemek medical center

City

'Afula

ZIP/Postal Code

18341

Country

Israel

Facility Name

Shalvata Hospital

City

Hod Hasharon

Country

Israel

12. IPD Sharing Statement

Links:

URL

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

Description

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

Learn more about this trial

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

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