Neural Correlates of Psychiatric Disorders

NCT04725409 | Recruiting

• 2 other identifiers: 211037251231
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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, as well as IRB #251231. 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.

Conditions

Psychiatric Disorder; Memory Disorders

Keywords

Depression; Stereo Electroencephalography (SEEG); Anxiety; Obsessive compulsive disorder; Impulsivity; Memory

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• Single unit neuronal spiking changes in response to study tasks

  Single neuron (single unit) spiking activity is recorded through SEEG micro neural recordings in response to patients completing neuro cognitive tasks.

  During patient's epilepsy monitoring stay, approximately 20-30 minutes

Study Arms (1)

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. Some subjects will also undergo macro-micro electrode implantation as a part of their SEEG implantation procedure for the purpose of EEG macro (local activity) and micro (single-unit) recordings.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

EEG recordings

MeSH Terms

Conditions

Mental Disorders; Memory Disorders; Depression; Anxiety Disorders; Obsessive-Compulsive Disorder; Impulsive Behavior

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Sarah Bick, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Long, BS

CONTACT

615-421-3046; Isabel.Long@vumc.org

Sarah Bick, MD

CONTACT

615-343-9822; Sarah.Bick@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery, Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 26, 2021
• Study Start: March 31, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)