SEEG Investigation of Mood Dysregulation in Epilepsy

NCT03097809 | Completed

• 1 other identifier: 15-1007
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

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

Epilepsy Subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Amit Anand, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: February 27, 2017
• Primary Completion: January 30, 2018
• Study Completion: July 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)