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Completed

NCT Number: NCT03097809

SEEG Investigation of Mood Dysregulation in Epilepsy

Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal will investigate the activity and connectivity of mood regulation circuits in subjects with suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of seizure activity.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

About this study

It is well known that epilepsy is associated with mood dysregulation including symptoms of labile mood, impulse control problems, anxiety, depression and increase in incidence of suicide. However, until present the neurobiological basis of mood dysregulation in epilepsy has not been clear and has been mostly attributed to a psychological reaction to the illness. This has severely limited our understanding of the impairments in mood regulation that people with epilepsy often experience and has also limited the development of effective treatment for ameliorating psychosocial dysfunction in people with epilepsy. The identification of these circuits will not only increase our understanding of mood-regulation in epilepsy but also possibly provide biomarkers with which the effectiveness of new treatments can be investigated. Developing better diagnostic measures and treatments for mood dysregulation will be highly beneficial to the quality of life of subjects suffering from epilepsy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis

Exclusion criteria

  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

Treatment and study plan

SEEG Recordings

Other

To directly record brain activity from the frontal-limbic circuitry of subjects in the resting state and while they engage in behavioral tasks designed to assess emotional response to negative stimuli and different aspects of impulse control and emotional processing

Primary outcomes

  1. Emotional Face Task and Emotional Go-No Go Task

    Time frame: 2 years

    To use face pictures depicting negative, positive and neutral emotions this task measures brain area activation abnormalities while responding and inhibiting responses to positive and negative emotions.

  2. Maintaining and suppressing emotions

    Time frame: 2 years

    To use the International Affective Picture System, subjects will be asked to either maintain or suppress their emotions.

  3. Resting state cortico-limbic brain connectivity

    Time frame: 2 years

    Resting state recordings will be collected from the cortical areas - prefrontal cortex, orbitofrontal cortex and anterior and posterior cingulate cortex as well as limbic areas - amygdala and hippocampus

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

SEEG Investigation of Mood Dysregulation in People With Epilepsy

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Mar 31, 2017
Registry last updated
Jul 14, 2020

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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