Neural Correlates of Psychiatric Disorders

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04725409

Collaborator

(none)

100

Enrollment

Location

58.1

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorder Memory Disorders

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Neural Correlates of Neuropsychiatric Functions

Actual Study Start Date :

Mar 31, 2021

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Epilepsy patients All participants will be patients with medically refractory epilepsy undergoing depth electrode placement for seizure localization. For this study participants will complete psychiatric questionnaires measuring depression, anxiety, obsessive compulsive disorder, and impulsivity, and EEG recordings will be collected from the depth electrodes while subjects rest quietly. Some subjects will also participate in neuro cognitive tasks while neural recordings/stimulation are performed.

Arm

Intervention/Treatment

Epilepsy patients

All participants will be patients with medically refractory epilepsy undergoing depth electrode placement for seizure localization. For this study participants will complete psychiatric questionnaires measuring depression, anxiety, obsessive compulsive disorder, and impulsivity, and EEG recordings will be collected from the depth electrodes while subjects rest quietly. Some subjects will also participate in neuro cognitive tasks while neural recordings/stimulation are performed.

Outcome Measures

Primary Outcome Measures

Neural activity correlating with the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) [During patient's epilepsy monitoring stay, approximately 15 minutes]
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
Neural activity correlating with the State-Trait Anxiety Inventory (STAI) [During patient's epilepsy monitoring stay, approximately 15 minutes]
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
Neural activity correlating with the Yale-Brown Obsessive Compulsive Scale (YBOCS) [During patient's epilepsy monitoring stay, approximately 15 minutes]
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
Neural activity correlating with the Barratt Impulsiveness Scale (BIS11) [During patient's epilepsy monitoring stay, approximately 15 minutes]
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
Local field potential changes in response to study tasks [During patient's epilepsy monitoring stay, approximately 20-30 minutes]
These local field potential changes are neural recordings in response to the stop signal tasks and n back tasks. In the stop signal reaction time task the subject will see a visual stimulus and be asked to press a button to respond. On some trials an auditory stimulus will also be presented which will indicate that the subject should not press the response button (they should suppress their response). In the n-back verbal working memory task the subject will see a series of words presented sequentially on a screen. During each word presentation the subject will press a button to indicate whether or not the word matches that presented n trials prior
Behavioral performance changes with stimulation [During patient's epilepsy monitoring stay, approximately 20-30 minutes]
Stimulation will occur during the stop signal task and n back task. In the stop signal reaction time task the subject will see a visual stimulus and be asked to press a button to respond. On some trials an auditory stimulus will also be presented which will indicate that the subject should not press the response button (they should suppress their response). In the n-back verbal working memory task the subject will see a series of words presented sequentially on a screen. During each word presentation the subject will press a button to indicate whether or not the word matches that presented n trials prior. Stimulation will be delivered through pre-selected SEEG electrodes via the Ripple Neuromed Summit system. Test stimulation will be performed prior to stimulation during the task to test for safety and tolerability, with the patient monitored for symptoms by a neurosurgeon or neurologist.