EpilepsyNCT02781129
Navigation and Free Recall in Chronically Implanted Humans
A study testing electrical stimulation in people with Epilepsy, run by Barbara Jobst at 1 site in United States.
Trial summary
This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to give informed consent
- 18 years of age or older
- Diagnosis of epilepsy
- Implanted RNS® device and receiving therapeutic stimulation for epilepsy.
- Capable of completing experimental tasks in the judgment of the Principal Investigator
Who cannot join
- RNS® Neurostimulator implanted within 3 months of experimental tasks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center in Lebanon, NH
Lebanon, New Hampshire, 03766
About this study
Official title: Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans
This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.
- Conditions
- Epilepsy
- Being tested
- electrical stimulation
- Keywords
- Memory, Responsive Neurostimulator System
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationOther
Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .
| Study group | Role | What they receive |
|---|---|---|
| RNS® Neurostimulator | Experimental | Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator. Receives: Other: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of words recalled with and without stimulation.
This study is designed to study the effects of therapeutic stimulation for epilepsy on memory. This outcome will be assessed by free recall language and memory tasks.
Measured: 30 days
Secondary outcomes (3)
Changes in the power spectrum of ECoG data with an increase of recalled words.
This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device. This outcome will be assessed by free recall language and memory tasks.
Measured: 30 days
Proportion of words recalled during times of interictal activity.
This study is designed to investigate the effects of IEDs on spatial, long-term, and short-term memory. This will be assessed by free recall language and memory tasks.
Measured: 30 days
Proportion of navigation challenges recalled successfully with and without stimulation.
This outcome will be assessed by real-world and virtual navigation tasks.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2025
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jobst
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroPace
- Responsible party
- Sponsor-investigator, Barbara Jobst, Dartmouth-Hitchcock Medical Center
- Investigators
- Barbara C Jobst, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781129
- Sponsor's protocol ID
- D16119
- Status last verified
- Jul 2025
- First submitted
- 5 May 2016
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans
- ClinicalTrials.gov ID
- NCT02781129
- Acronym / sponsor ID
- D16119
- Conditions
- Epilepsy
- Keywords
- Memory, Responsive Neurostimulator System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Barbara JobstUniversity, hospital or other
- Collaborators
- NeuroPace
- Study start
- May 2016 (actual)
- Primary completion
- May 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 24 May 2016 (estimated)
- 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 study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RNS® Neurostimulator | Experimental | Other: electrical stimulationSubjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- able to give informed consent
- 18 years of age or older
- Diagnosis of epilepsy
- Implanted RNS® device and receiving therapeutic stimulation for epilepsy.
- Capable of completing experimental tasks in the judgment of the Principal Investigator
Key exclusion criteria (1 listed)
- RNS® Neurostimulator implanted within 3 months of experimental tasks.
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 |
|---|---|---|
| electrical stimulationStimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance . | Other | RNS® Neurostimulator |
Primary outcome
Proportion of words recalled with and without stimulation.
Time frame: 30 days
This study is designed to study the effects of therapeutic stimulation for epilepsy on memory. This outcome will be assessed by free recall language and memory tasks.
3 secondary outcomes
Changes in the power spectrum of ECoG data with an increase of recalled words.
Time frame: 30 days
Proportion of words recalled during times of interictal activity.
Time frame: 30 days
Proportion of navigation challenges recalled successfully with and without stimulation.
Time frame: 30 days
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 30 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Enrolling by invitationObservational study
Study of Direct Brain Recording and Stimulation for Memory Enhancement
Epilepsy
RecruitingObservational study
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
Epilepsy
Not yet recruiting
Biomarker Targeted Stimulation for Epileptiform Events
Epilepsy
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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.
Barbara C Jobst, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Epilepsy, run by Barbara Jobst 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 5 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 30 Jul 2025. 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?
Proportion of words recalled with and without stimulation. (time frame: 30 days). 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 30 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.