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NCT Number: NCT04725409

Neural Correlates of Psychiatric Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Sarah Bick, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Neural activity correlating with the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)

    Time frame: 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

  2. Neural activity correlating with the State-Trait Anxiety Inventory (STAI)

    Time frame: 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

  3. Neural activity correlating with the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: 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

  4. Neural activity correlating with the Barratt Impulsiveness Scale (BIS11)

    Time frame: 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

  5. Local field potential changes in response to study tasks

    Time frame: 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

  6. Behavioral performance changes with stimulation

    Time frame: 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.

  7. Single unit neuronal spiking changes in response to study tasks

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lucas Chang, BA

CONTACT

[email protected]

615-421-3046

Sarah Bick, MD

CONTACT

[email protected]

615-343-9822

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Neural Correlates of Neuropsychiatric Functions

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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