Neural Correlates of Psychiatric Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record:
This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing SEEG monitoring at Vanderbilt University Medical Center
At least 18 years of age
English speaking
Disqualifiers
Age <18
Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)
Trial population
Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Epilepsy patients
Trial outcomes
Primary outcomes
1
Neural activity correlating with the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) is a commonly used and well validated depression screening tool consisting of 20 questions. Scores range from 0 to 60 and a score of 16 or above indicates a risk for clinical depression. CESD-R scores will be correlated with resting state measures of neural activity and connectivity
Time frame
During patient's epilepsy monitoring stay, approximately 15 minutes2
Neural activity correlating with the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a validated anxiety scale that screens for current anxiety state and chronic anxiety trait. It consists of 40 questions with scores ranging from 20 to 80. A score of 40 or above indicates risk of anxiety. STAI scores will be correlated with resting state measures of neural activity and connectivity
Time frame
During patient's epilepsy monitoring stay, approximately 15 minutes3
Neural activity correlating with the Yale-Brown Obsessive Compulsive Scale (YBOCS)
The Yale-Brown Obsessive Compulsive Scale (YBOCS) is the most commonly used and well validated measure of obsessive compulsive features. It consists of 10 questions with scores ranging from 0 to 40. A score of 8-15 indicates mild OCD, 16-23 indicates moderate OCD, 24-31 indicates severe OCD and 32-40 indicates extreme OCD. YBOCS scores will be correlated with resting state measures of neural activity and connectivity
Time frame
During patient's epilepsy monitoring stay, approximately 15 minutes4
Neural activity correlating with the Barratt Impulsiveness Scale (BIS11)
The Barratt Impulsiveness Scale (BIS11) is a well validated measure of impulsive traits that consists of 30 questions. The scores of the BIS11 range from 30 to 120 with scores above 72 indicating high levels of impulsivity. BIS11 scores will be correlated with resting state measures of neural activity and connectivity
Time frame
During patient's epilepsy monitoring stay, approximately 15 minutesSponsors and contacts
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Source ClinicalTrials.gov