EpilepsyNCT05200455
Microelectrodes in Epilepsy
A study testing Microelectrodes in people with Epilepsy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Microelectrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2009to 18 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 year old
- male or female
- right or left handed
- IQ>70
- medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
- no contraindications to intracranial electrode study
- able and willing to participate in research
Who cannot join
- does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.
Read the detailed description
The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.
- Conditions
- Epilepsy
- Being tested
- Microelectrodes
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroelectrodesDevice
Microelectrode implantation
| Study group | Role | What they receive |
|---|---|---|
| Microelectrodes | Experimental | Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring. Receives: Device: Microelectrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.
With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated.
Measured: Evaluated for each patient during monitoring period of approximately 2 weeks
Secondary outcomes (1)
How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).
Secondary objective is to investigate whether it is possible to predict the speed of which each participant is performing and navigating during the cognitive task via the intracranial spectral EEG changes (alpha, beta, delta, theta, gamma, and high-gamma) during these tasks. Accuracy of frequency band (brain waves) predicting speed during specific cognitive tasks is measured by how precisely the frequency band predicts navigational speed and is expressed as a percentage of correct prediction.
Measured: Evaluated for each patient during monitoring period of approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start18 Sep 2009
- Primary completion30 Mar 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Barbara Jobst, Dartmouth-Hitchcock Medical Center
- Investigators
- Barbara C Jobst, MD, PhD, Principal investigator, Section Chief of Adult Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200455
- Sponsor's protocol ID
- STUDY00021993
- Other IDs
- 1R01NS074450-01
- Status last verified
- Aug 2022
- First submitted
- 7 Jan 2022
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microelectrodes in Epilepsy
- ClinicalTrials.gov ID
- NCT05200455
- Acronym / sponsor ID
- STUDY00021993
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Sep 2009 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.
Detailed description
The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microelectrodes | Experimental | Device: MicroelectrodesPatients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 year old
- male or female
- right or left handed
- IQ>70
- medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
Key exclusion criteria (1 listed)
- does not meet the inclusion criteria
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 |
|---|---|---|
| MicroelectrodesMicroelectrode implantation | Device | Microelectrodes |
Primary outcome
Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.
Time frame: Evaluated for each patient during monitoring period of approximately 2 weeks
With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated.
1 secondary outcome
How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).
Time frame: Evaluated for each patient during monitoring period of approximately 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Barbara C Jobst, MD, PhD principal investigator
Section Chief of Adult Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microelectrodes in people with Epilepsy, run by Dartmouth-Hitchcock 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 7 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 7 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?
Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons. (time frame: Evaluated for each patient during monitoring period of approximately 2 weeks). 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 7 Sep 2022.