Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT04725409

Conditions

Psychiatric Disorder

Memory Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Psychiatric Disorder

Memory Disorders

Study ID

NCT04725409

Start date

Mar 31, 2021

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 ]
  • Neural activity correlating with the State-Trait Anxiety Inventory (STAI) [ Time Frame: During patient's epilepsy monitoring stay, approximately 15 minutes ]
  • Neural activity correlating with the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: During patient's epilepsy monitoring stay, approximately 15 minutes ]
  • Neural activity correlating with the Barratt Impulsiveness Scale (BIS11) [ Time Frame: During patient's epilepsy monitoring stay, approximately 15 minutes ]
  • Local field potential changes in response to study tasks [ Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes ]
  • Behavioral performance changes with stimulation [ Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes ]
  • Single unit neuronal spiking changes in response to study tasks [ Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes ]

Central Contacts and Locations

Central contacts

Lucas Chang, BA

615-421-3046lucas.m.chang@vumc.org

Sarah Bick, MD

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 12, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-12.