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CompletedNCT02523105Updated Apr 26, 2018

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

An interventional study of EEG monitoring in Depression, sponsored by Brainmarc Ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Brainmarc Ltd. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 37 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Brainmarc Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Other
    Participants diagnosed with depression.

    EEG monitoring and evaluation

    Device: EEG monitoring

  • Other
    Healthy participants.

    EEG monitoring and evaluation

    Device: EEG monitoring

Interventions

  • DeviceEEG 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.

06

What researchers measure

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.

    Time frame: 12 months

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Study locations

2 sites
  • Haemek medical center
    'Afula, 18341, Israel
  • Shalvata Hospital
    Hod Hasharon, Israel
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02523105
Lead sponsor
Brainmarc Ltd.
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Sep 2015
Primary completion
Oct 9, 2016
Completion
Jan 5, 2017
Last update
Apr 26, 2018

Study contacts

Yuval Bloch, MD
principal investigator · Shalvata Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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