SEEG Investigation of Mood Dysregulation in Epilepsy

Epilepsy Clinical Trial

Official title:

SEEG Investigation of Mood Dysregulation in People With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097809
• Other study ID #: 15-1007
• Status: Completed
• Start date: February 27, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 1, 2020
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation Center for Behavioral Health	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maintaining and suppressing emotions	To use the International Affective Picture System, subjects will be asked to either maintain or suppress their emotions.	2 years
Primary	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