Psychiatric DisorderNCT04725409
Neural Correlates of Psychiatric Disorders
An observational study of Psychiatric Disorder and Memory Disorders, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder, Memory Disorders
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures.
Who may be able to join
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- At least 18 years of age
- English speaking
Who cannot join
- Age <18
- Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Sarah Bick, MD
About this study
Official title: Neural Correlates of Neuropsychiatric Functions
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
- Keywords
- Depression, Stereo Electroencephalography (SEEG), Anxiety, Obsessive compulsive disorder, Impulsivity, Memory
- Medical subject headings
- Mental Disorders, Memory Disorders, Depression, Anxiety Disorders, Obsessive-Compulsive Disorder, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During patient's epilepsy monitoring stay, approximately 15 minutes
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
Measured: During patient's epilepsy monitoring stay, approximately 15 minutes
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
Measured: During patient's epilepsy monitoring stay, approximately 15 minutes
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
Measured: During patient's epilepsy monitoring stay, approximately 15 minutes
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
Measured: During patient's epilepsy monitoring stay, approximately 20-30 minutes
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.
Measured: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Single unit neuronal spiking changes in response to study tasks
Single neuron (single unit) spiking activity is recorded through SEEG micro neural recordings in response to patients completing neuro cognitive tasks.
Measured: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start31 Mar 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Bick, Vanderbilt University Medical Center
- Investigators
- Sarah Bick, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725409
- Sponsor's protocol ID
- 211037
- Status last verified
- May 2026
- First submitted
- 14 Jan 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Neuropsychiatric Functions
- ClinicalTrials.gov ID
- NCT04725409
- Acronym / sponsor ID
- 211037
- Conditions
- Psychiatric Disorder, Memory Disorders
- Keywords
- Depression, Stereo Electroencephalography (SEEG), Anxiety, Obsessive compulsive disorder, Impulsivity, Memory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures.
Key inclusion criteria (3 listed)
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- At least 18 years of age
- English speaking
Key exclusion criteria (2 listed)
- Age <18
- Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Bick, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Memory Disorders, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas Chang, BA (615-421-3046, lucas.m.chang@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.