SEEG Investigation of Mood Dysregulation in Epilepsy

NCT ID: NCT03097809

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2020-07-01

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SEEG Recordings

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amit Anand, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Anand, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

15-1007

Identifier Type: -

Identifier Source: org_study_id