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Neural Correlates of Psychiatric Disorders

Neural Correlates of Neuropsychiatric Functions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04725409
Enrollment
100
Registered
2021-01-26
Start date
2021-03-31
Completion date
2027-12-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Disorders, Psychiatric Disorder

Keywords

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

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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Neural activity correlating with the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)During patient's epilepsy monitoring stay, approximately 15 minutesThe 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 minutesThe 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 minutesThe 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 minutesThe 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 tasksDuring patient's epilepsy monitoring stay, approximately 20-30 minutesThese 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 stimulationDuring patient's epilepsy monitoring stay, approximately 20-30 minutesStimulation 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.
Single unit neuronal spiking changes in response to study tasksDuring patient's epilepsy monitoring stay, approximately 20-30 minutesSingle neuron (single unit) spiking activity is recorded through SEEG micro neural recordings in response to patients completing neuro cognitive tasks.

Countries

United States

Contacts

CONTACTLucas Chang, BA
lucas.m.chang@vumc.org615-421-3046
CONTACTSarah Bick, MD
Sarah.Bick@vumc.org615-343-9822
PRINCIPAL_INVESTIGATORSarah Bick, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026