Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04725409
Other study ID # 211037
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 31, 2021
Est. completion date February 2026

Study information

Verified date July 2023
Source Vanderbilt University Medical Center
Contact Sarah Bick, MD
Phone 615-322-1883
Email Sarah.Bick@vumc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03409991 - Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities N/A
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT04778163 - The Use of Humor With Young Adults in Psychiatric Care N/A
Not yet recruiting NCT06304363 - Braining - Evaluation of Acute Effects of Physical Exercise N/A
Recruiting NCT04096625 - Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS) N/A
Not yet recruiting NCT05930353 - Psychometric Validation of a French-language Version of the PERMA-Profiler: Tools for Assessing Multidimensional Subjective Well-being
Terminated NCT06012981 - Psychological Treatment in Psychiatric Inpatient Care N/A
Completed NCT04099173 - A Brief Mindfulness-Based Intervention for Suicidal Ideation N/A
Completed NCT01866956 - Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders
Recruiting NCT04249960 - Sustain and Reinforce the Transition From Child to Adult Mental Health Care in Switzerland : A Monocentric Nested Cohort Randomized Controlled Trial: The SORT Study. N/A
Recruiting NCT05962424 - HNC: Human Neural Circuits Electrophysiology During Cognition Phase 1
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Recruiting NCT03678194 - Treating Depression on a Day-to-day Basis: Development of a Tool for Physicians Based on a Smartphone Application N/A
Completed NCT03748355 - Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects N/A
Completed NCT05473962 - Mid-Term Follow-up Assessment After Exposure to Natural Disaster
Recruiting NCT05577585 - Ketamine and Stress in OCD N/A
Completed NCT05124158 - COVID-19 Severity and Psychiatric Morbidity
Recruiting NCT05560581 - Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy N/A
Completed NCT04618250 - Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA) N/A
Not yet recruiting NCT06014164 - Qualitative Study About Psychedelics Using in Psychiatric Disorders