SEEG Investigation of Mood Dysregulation in Epilepsy

SEEG Investigation of Mood Dysregulation in People With 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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: SEEG Recordings

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation Center for Behavioral Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects from the Epilepsy Center at the Cleveland Clinic for surgical treatment of medically refractory epilepsy who would have already had SEEG electrodes placed in cortical and limbic areas for clinical diagnostic purposes

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy Subjects; 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.	Other: SEEG Recordings; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 15-1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No