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Recruiting NCT04725409

Neural Correlates of Psychiatric Disorders

Observational Psychiatric Disorder Memory Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psychiatric Disorder, Memory Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neural Correlates of Neuropsychiatric Functions

Overview

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.

Primary outcome measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT04725409 · 211037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗