Memory DisordersNCT07617506
Neural Basis of Human Working Memory
A study testing Neurocognitive Tasks and Ripple Neuromed Summit System in people with Memory Disorders, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231. This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Memory Disorders
- What is being tested?
- Neurocognitive Tasks and Ripple Neuromed Summit System
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- Age >18
- English speaking
Who cannot join
- Age <18
- Not able to complete questionnaires (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
Lucas Chang, BA, 615-421-3046, lucas.m.chang@vumc.org
Christos Constantinidis, PhD, (615) 936 - 2020, christos.constantinidis.1@Vanderbilt.Edu
About this study
This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.
This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.
- Conditions
- Memory Disorders
- Being tested
- Neurocognitive Tasks, Ripple Neuromed Summit System
- Keywords
- Neural stimulation, Memory disorders, Working Memory, Stereo Electroencephalography (SEEG)
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive TasksBehavioural
Participants complete computerized neurocognitive tasks assessing working memory, response inhibition, decision-making, reward processing, and other related cognitive functions during sEEG monitoring. Tasks may include the stop signal reaction time task, the n-back working memory task, the delayed response task, the match/nonmatch task, the gambling task, the card guessing task, and the emotional stop signal reaction time task. Intracranial neural activity is recorded during task performance, and select tasks may include research electrical stimulation delivered through the implanted sEEG electrodes.
Ripple Neuromed Summit SystemDevice
Neurophysiology system designed to allow recording of neural signals as well as delivery of neural stimulation. The system is a portable unit which is connected to cables connected to the clinical electrodes. Neurophysiology signals from the electrodes can be recorded, amplified, and processed by the unit. The unit also has the ability to deliver electrical stimulation through the electrodes according to programmed parameters.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients | Other | All participants will be patients with medically refractory epilepsy who have undergone depth electrode placement for stereo EEG monitoring for seizure localization. Participants will complete working memory tasks and EEG recordings will be concurrently collected from their depth electrodes. Some subjects will 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. Some subjects will complete working memory tasks with stimulation applied during task completion. Receives: Behavioral: Neurocognitive Tasks; Device: Ripple Neuromed Summit System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local field potential changes in response to working memory tasks
Local field potential changes are from intracranial neural recordings taken while patients complete spatial working memory tasks. In the manual remember 1 remember 2 task, patients are instructed to hold down a cursor on a central location box colored one color or another on screen, while two boxes in locations sequentially flash on screen. Depending on the central location box color, the patient will drag their cursor to the first or second location box shown, after the central box has disappeared from screen. In the retro remember 1 remember 2 task, the color of the central box color is not shown until both location boxes have flashed onscreen. In the manual version, the central location box color is constant throughout the trial.
Measured: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Single unit neuronal spiking changes in response to memory tasks
Single neuron spiking activity is recorded through SEEG micro neural recordings while patients complete working memory tasks.
Measured: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Behavioral performance changes with stimulation
Bipolar stimulation through pre-selected SEEG electrodes in the prefrontal cortex and surrounding areas will occur during the remember 1 remember 2 working memory tasks. Stimulation will be performed via the Ripple Neuromed Summit system. Stimulation will be tested with each patient prior to task to determine safety and tolerability, while patient is monitored by a neurosurgeon or neurologist.
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 posted1 Jun 2026
- Study start4 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Christos Constantinidis, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617506
- Sponsor's protocol ID
- 251231
- Other IDs
- 1R21MH139624-01
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Basis of Human Working Memory
- ClinicalTrials.gov ID
- NCT07617506
- Acronym / sponsor ID
- 251231
- Conditions
- Memory Disorders
- Keywords
- Neural stimulation, Memory disorders, Working Memory, Stereo Electroencephalography (SEEG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Jun 2026 (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 ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.
This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | Other | Behavioral: Neurocognitive Tasks, Device: Ripple Neuromed Summit SystemAll participants will be patients with medically refractory epilepsy who have undergone depth electrode placement for stereo EEG monitoring for seizure localization. Participants will complete working memory tasks and EEG recordings will be concurrently collected from their depth electrodes. Some subjects will 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. Some subjects will complete working memory tasks with stimulation applied during task completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- Age >18
- English speaking
Key exclusion criteria (2 listed)
- Age <18
- Not able to complete questionnaires (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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive TasksParticipants complete computerized neurocognitive tasks assessing working memory, response inhibition, decision-making, reward processing, and other related cognitive functions during sEEG monitoring. Tasks may include the stop signal reaction time task, the n-back working memory task, the delayed response task, the match/nonmatch task, the gambling task, the card guessing task, and the emotional stop signal reaction time task. Intracranial neural activity is recorded during task performance, and select tasks may include research electrical stimulation delivered through the implanted sEEG electrodes. | Behavioural | Epilepsy patients |
| Ripple Neuromed Summit SystemNeurophysiology system designed to allow recording of neural signals as well as delivery of neural stimulation. The system is a portable unit which is connected to cables connected to the clinical electrodes. Neurophysiology signals from the electrodes can be recorded, amplified, and processed by the unit. The unit also has the ability to deliver electrical stimulation through the electrodes according to programmed parameters. | Device | Epilepsy patients |
Primary outcome
Local field potential changes in response to working memory tasks
Time frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Local field potential changes are from intracranial neural recordings taken while patients complete spatial working memory tasks. In the manual remember 1 remember 2 task, patients are instructed to hold down a cursor on a central location box colored one color or another on screen, while two boxes in locations sequentially flash on screen. Depending on the central location box color, the patient will drag their cursor to the first or second location box shown, after the central box has disappeared from screen. In the retro remember 1 remember 2 task, the color of the central box color is not shown until both location boxes have flashed onscreen. In the manual version, the central location box color is constant throughout the trial.
Single unit neuronal spiking changes in response to memory tasks
Time frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Single neuron spiking activity is recorded through SEEG micro neural recordings while patients complete working memory tasks.
Behavioral performance changes with stimulation
Time frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
Bipolar stimulation through pre-selected SEEG electrodes in the prefrontal cortex and surrounding areas will occur during the remember 1 remember 2 working memory tasks. Stimulation will be performed via the Ripple Neuromed Summit system. Stimulation will be tested with each patient prior to task to determine safety and tolerability, while patient is monitored by a neurosurgeon or neurologist.
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 24 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Tasks and Ripple Neuromed Summit System in people with 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 24 Aug 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, BS (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?
Local field potential changes in response to working memory tasks (time frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes). The study lists 3 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 24 Aug 2026.