SEEG Investigation of Mood Dysregulation in Epilepsy

Completed

• Conditions: Epilepsy
• Interventions: Other: SEEG Recordings

• Registration Number: NCT03097809
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Primary Completion: 2018-01-30
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy Subjects	SEEG Recordings	Subjects will be recruited from the epilepsy-monitoring unit. These subjects would have been already assessed by the Epilepsy Center at the Cleveland Clinic for surgical treatment of medically refractory epilepsy and would have already had SEEG electrodes placed in cortical and limbic areas for clinical diagnostic purposes.

Primary Outcome Measures

Name	Time	Method
Resting state cortico-limbic brain connectivity	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
Emotional Face Task and Emotional Go-No Go Task	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.
Maintaining and suppressing emotions	2 years	To use the International Affective Picture System, subjects will be asked to either maintain or suppress their emotions.

Trial Locations

Locations (1)

Cleveland Clinic Foundation Center for Behavioral Health; 🇺🇸 Cleveland, Ohio, United States