Clinical trial NCT04725409: Neural Correlates of Psychiatric Disorders
Official title: Neural Correlates of Neuropsychiatric Functions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychiatric Disorder
Memory Disorders
Keywords: Depression
Stereo Electroencephalography (SEEG)
Anxiety
Obsessive compulsive disorder
Impulsivity
Memory
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures.

Brief summary: 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: Inclusion Criteria:

* Undergoing SEEG monitoring at Vanderbilt University Medical Center
* At least 18 years of age
* English speaking

Exclusion Criteria:

* Age \<18
* Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)

Primary outcomes:
measure: Neural activity correlating with the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
timeFrame: During patient's epilepsy monitoring stay, approximately 15 minutes
measure: Neural activity correlating with the State-Trait Anxiety Inventory (STAI)
timeFrame: During patient's epilepsy monitoring stay, approximately 15 minutes
measure: Neural activity correlating with the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: During patient's epilepsy monitoring stay, approximately 15 minutes
measure: Neural activity correlating with the Barratt Impulsiveness Scale (BIS11)
timeFrame: During patient's epilepsy monitoring stay, approximately 15 minutes
measure: Local field potential changes in response to study tasks
timeFrame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
measure: Behavioral performance changes with stimulation
timeFrame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
measure: Single unit neuronal spiking changes in response to study tasks
timeFrame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sarah Bick, MD
role: PRINCIPAL_INVESTIGATOR
References: