Epilepsy, Complex PartialNCT04573569
Neural Correlates of Cognition and Mood
An observational study of Epilepsy, Complex Partial, run by University of Minnesota at 1 site in United States.
Trial summary
The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Complex Partial
- What is being tested?
- Behavioral testing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing Phase II surgical epilepsy localization
Who may be able to join
- Patient is able to consent for themselves and the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. In the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. As such, this study has the following specific aims:
Aim 1: Establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ECoG/SEEG recording platform Aim 2: Quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase II epilepsy monitoring Aim 3: Assess the relationship between validated surveys/tasks and electrophysiology
Read the detailed description
Study interventions are limited entirely to validated surveys completed on a computer or tablet PC, as outlined above. Patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are FDA-approved for the same indications. Patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer.
The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. As this is a feasibility study, we are interested in the practical aspects of data acquisition.
Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology.
- Conditions
- Epilepsy, Complex Partial
- Being tested
- Behavioral testing
- Medical subject headings
- Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral testingBehavioural
Patients recruited for this study have already undergone surgical implantation of invasive electrodes for purpose of localizing and characterizing electrographic seizures as part of the second phase of surgical epilepsy evaluation. Patients who consent and complete enrollment will then be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer. These tasks are performed at the will of each patient during their stay in the intensive care unit while surgical electrodes remain.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of completed cognitive tasks
The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. We are interested in the practical aspects of data acquisition. No comparison is made as no baseline data exists ECoG, SEEG recordings, and eye-tracking data are timestamped, this allows the validated surveys and tasks to be linked precisely. These results will establish the response rate to the intervention allowing calculation of the number of events to use in establishing relationships with the underlying physiology.
Measured: Up to 1 month (Assessments start after Post-operative day 2)
Secondary outcomes (1)
Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology of the brain.
Event-related potential will be calculated using time synchronized ECoG or SEEG recordings. Averaging will be performed across each task for event-related potentials and compared with shuffled data for bootstrapping about the median. Alpha is selected to be 0.05 with the Bonferroni correction with the number of tests. Causal inference will be used to assess the relationship between the various electrodes. Causal metrics including multivariate Granger causality and Transfer Entropy will be used to assess the adjacency matrices. Statistics are performed with shuffled bootstrapping also using the Bonferroni adjustment on the number of channels. The relationship between pupil size, gaze location, task behavior and E-phys measures will be assessed with generalized linear models, generalized canonical correlation analysis, and structured equation models.
Measured: Up to 1 month (Assessments start after Post-operative day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start28 Mar 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Complex PartialStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573569
- Sponsor's protocol ID
- NEUROSURG-2019-28063
- Status last verified
- Sep 2022
- First submitted
- 16 Dec 2018
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Cognition and Mood
- ClinicalTrials.gov ID
- NCT04573569
- Acronym / sponsor ID
- NEUROSURG-2019-28063
- Conditions
- Epilepsy, Complex Partial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Oct 2020 (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.
The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. In the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. As such, this study has the following specific aims:
Aim 1: Establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ECoG/SEEG recording platform Aim 2: Quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase II epilepsy monitoring Aim 3: Assess the relationship between validated surveys/tasks and electrophysiology
Detailed description
Study interventions are limited entirely to validated surveys completed on a computer or tablet PC, as outlined above. Patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are FDA-approved for the same indications. Patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer.
The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. As this is a feasibility study, we are interested in the practical aspects of data acquisition.
Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing Phase II surgical epilepsy localization
Key inclusion criteria (1 listed)
- Patient is able to consent for themselves and the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral testingPatients recruited for this study have already undergone surgical implantation of invasive electrodes for purpose of localizing and characterizing electrographic seizures as part of the second phase of surgical epilepsy evaluation. Patients who consent and complete enrollment will then be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer. These tasks are performed at the will of each patient during their stay in the intensive care unit while surgical electrodes remain. | Behavioural | – |
Primary outcome
Percentage of completed cognitive tasks
Time frame: Up to 1 month (Assessments start after Post-operative day 2)
The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. We are interested in the practical aspects of data acquisition. No comparison is made as no baseline data exists ECoG, SEEG recordings, and eye-tracking data are timestamped, this allows the validated surveys and tasks to be linked precisely. These results will establish the response rate to the intervention allowing calculation of the number of events to use in establishing relationships with the underlying physiology.
1 secondary outcome
Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology of the brain.
Time frame: Up to 1 month (Assessments start after Post-operative day 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Epilepsy, Complex Partial, run by University of Minnesota 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of completed cognitive tasks (time frame: Up to 1 month (Assessments start after Post-operative day 2)). 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 10 Sep 2022.