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SEEG Investigation of Mood Dysregulation in Epilepsy

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ClinicalTrials.gov Identifier: NCT03097809
Recruitment Status : Enrolling by invitation
First Posted : March 31, 2017
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Amit Anand, MD, 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.

Condition or disease Intervention/treatment
Epilepsy 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: SEEG Investigation of Mood Dysregulation in People With Epilepsy
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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




Primary Outcome Measures :
  1. Emotional Face Task and Emotional Go-No Go Task [ Time Frame: 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.

  2. Maintaining and suppressing emotions [ Time Frame: 2 years ]
    To use the International Affective Picture System, subjects will be asked to either maintain or suppress their emotions.

  3. Resting state cortico-limbic brain connectivity [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097809


Locations
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United States, Ohio
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Amit Anand, MD The Cleveland Clinic

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Responsible Party: Amit Anand, MD, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03097809     History of Changes
Other Study ID Numbers: 15-1007
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases