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Completed

NCT Number: NCT02523105

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haemek medical center, Afula, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Brainmarc Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 14, 2015
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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