Neural Correlates of Psychiatric Disorders

Psychiatric Disorder Clinical Trial

Official title:

Neural Correlates of Neuropsychiatric Functions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725409
• Other study ID #: 211037
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: February 2026

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: Sarah Bick, MD
• Phone: 615-322-1883
• Email: Sarah.Bick[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Memory Disorders
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During patient's epilepsy monitoring stay, approximately 15 minutes
Primary	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	During patient's epilepsy monitoring stay, approximately 15 minutes
Primary	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	During patient's epilepsy monitoring stay, approximately 15 minutes
Primary	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	During patient's epilepsy monitoring stay, approximately 15 minutes
Primary	Local field potential changes in response to study tasks	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	During patient's epilepsy monitoring stay, approximately 20-30 minutes
Primary	Behavioral performance changes with stimulation	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.	During patient's epilepsy monitoring stay, approximately 20-30 minutes