EpilepsyNCT05755919
Functional Brain Mapping for Patients with Epilepsy
A study testing Epilepsy surgery in people with Epilepsy, run by Wayne State University at 2 sites in United States.
Trial summary
We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Epilepsy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2022to 31 Mar 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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Epilepsy surgery with extraoperative intracranial EEG recording with subdural or depth electrodes.
Who cannot join
- Patients with a malignant brain tumor, or progressive neurodegenerative or metabolic disorders who are not considered candidates for intracranial EEG recording.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Eishi Asano, MD, PhD, 313-745-5563, easano@med.wayne.edu
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Eishi Asano, MD, PhD, 313-745-5563, easano@med.wayne.edu
About this study
Official title: Functional Brain Mapping in Pediatric Neurosurgery
We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. We will also determine how well objective electrophysiology biomarkers will improve the prediction of language outcomes following epilepsy surgery. This project will ultimately optimize understanding of how the human brain develops its language network dynamics.
Read the detailed description
We will determine the utility of a novel brain mapping technique for epilepsy presurgical evaluation, referred to as 'six-dimensional (6D) dynamic tractography'. This innovative program animates the rapid neural propagations along MRI-defined, 3D white matter tracts that connect regions supporting cognitive functions. Specifically, it will use event-related high gamma activity to localize the regions supporting specific linguistic functions and compute the velocity and strength of neural propagations based on the latency and amplitude of early neural responses to single-pulse electrical stimulation. We expect that considering both the negative effect of damaged white matter tracts and the positive effect of seizure control will help optimize the model's performance in predicting postoperative language outcomes; this will be accomplished by incorporating the 6D dynamic tractography and objective epilepsy biomarkers, including spontaneous high-frequency oscillations (HFOs) coupled to slow-waves, into our predictive model. By also identifying and considering the physiological high gamma augmentation strictly time-locked to stimuli and behaviors, our innovative intracranial EEG analysis will better distinguish the randomly-occurring pathologic HFOs. Another significant advancement provided by our model is its independence of conventional electrical stimulation mapping, which can acutely elicit seizures and fail to satisfactorily localize language areas in certain patient subsets. Additionally, this project will use 6D dynamic tractography to provide an explicit neurobiological model of language network dynamics, allowing us to tease apart the specific pathways originating from temporal lobe cortices that support the lexical retrieval of auditory or visual domains. Our prior project indicated that the arcuate fasciculus fibers support the direct transfer of lexical representations of auditory sentences. We will now determine whether the lexical representations of visual objects are likewise transferred via the arcuate fasciculus or others, including the fusiform-parietal fasciculus. To accomplish these goals, this project will prospectively recruit a new cohort of 80 epilepsy patients - age range: 0.5 to 21 years - undergoing extraoperative intracranial EEG recording and subsequent resective surgery. Finally, we will determine if the human brain creates and strengthens language-related functional parcellations throughout development. It has been suggested that the adult brain efficiently activates the posterior superior-temporal gyrus (STG) only during sound onset to decode the boundary between sounds. In contrast, the anterior STG shows sustained activation during an auditory stimulus to encode the phonetic features. We will determine if such a functional parcellation is more evident in older individuals, whose brains are more developed. While providing hypotheses focusing on specific brain regions, we will perform all of the proposed analyses at the whole-brain level. We will make all data and codes publicly available to facilitate external validation and implementation.
- Conditions
- Epilepsy
- Being tested
- Epilepsy surgery
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epilepsy surgeryProcedure or surgery
Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with epilepsy | Other | Epilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy. Receives: Procedure: Epilepsy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language outcome
Neuropsychological scores
Measured: 1 year
Secondary outcomes (1)
Seizure outcome
ILAE classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start16 May 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eishi Asano, Wayne State University
- Investigators
- Eishi Asano, MD, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755919
- Sponsor's protocol ID
- 048404MP2E
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following data de-identification, we propose to share our datasets with the public via 'NeuroElectroMagnetic Data Archive and Tools Resource (NEMAR)' or 'iEEG.org', both of which are NIH-funded data-sharing platforms.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Mapping in Pediatric Neurosurgery
- ClinicalTrials.gov ID
- NCT05755919
- Acronym / sponsor ID
- 048404MP2E
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Mar 2023 (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.
We aim to determine the clinical utility of 'dynamic tractography': a novel method for visualizing electrical neural transfers that incorporates the underlying white matter tracts and supporting linguistic processing. We will also determine how well objective electrophysiology biomarkers will improve the prediction of language outcomes following epilepsy surgery. This project will ultimately optimize understanding of how the human brain develops its language network dynamics.
Detailed description
We will determine the utility of a novel brain mapping technique for epilepsy presurgical evaluation, referred to as 'six-dimensional (6D) dynamic tractography'. This innovative program animates the rapid neural propagations along MRI-defined, 3D white matter tracts that connect regions supporting cognitive functions. Specifically, it will use event-related high gamma activity to localize the regions supporting specific linguistic functions and compute the velocity and strength of neural propagations based on the latency and amplitude of early neural responses to single-pulse electrical stimulation. We expect that considering both the negative effect of damaged white matter tracts and the positive effect of seizure control will help optimize the model's performance in predicting postoperative language outcomes; this will be accomplished by incorporating the 6D dynamic tractography and objective epilepsy biomarkers, including spontaneous high-frequency oscillations (HFOs) coupled to slow-waves, into our predictive model. By also identifying and considering the physiological high gamma augmentation strictly time-locked to stimuli and behaviors, our innovative intracranial EEG analysis will better distinguish the randomly-occurring pathologic HFOs. Another significant advancement provided by our model is its independence of conventional electrical stimulation mapping, which can acutely elicit seizures and fail to satisfactorily localize language areas in certain patient subsets. Additionally, this project will use 6D dynamic tractography to provide an explicit neurobiological model of language network dynamics, allowing us to tease apart the specific pathways originating from temporal lobe cortices that support the lexical retrieval of auditory or visual domains. Our prior project indicated that the arcuate fasciculus fibers support the direct transfer of lexical representations of auditory sentences. We will now determine whether the lexical representations of visual objects are likewise transferred via the arcuate fasciculus or others, including the fusiform-parietal fasciculus. To accomplish these goals, this project will prospectively recruit a new cohort of 80 epilepsy patients - age range: 0.5 to 21 years - undergoing extraoperative intracranial EEG recording and subsequent resective surgery. Finally, we will determine if the human brain creates and strengthens language-related functional parcellations throughout development. It has been suggested that the adult brain efficiently activates the posterior superior-temporal gyrus (STG) only during sound onset to decode the boundary between sounds. In contrast, the anterior STG shows sustained activation during an auditory stimulus to encode the phonetic features. We will determine if such a functional parcellation is more evident in older individuals, whose brains are more developed. While providing hypotheses focusing on specific brain regions, we will perform all of the proposed analyses at the whole-brain level. We will make all data and codes publicly available to facilitate external validation and implementation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with epilepsy | Other | Procedure: Epilepsy surgeryEpilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Epilepsy surgery with extraoperative intracranial EEG recording with subdural or depth electrodes.
Key exclusion criteria (1 listed)
- Patients with a malignant brain tumor, or progressive neurodegenerative or metabolic disorders who are not considered candidates for intracranial EEG recording.
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 |
|---|---|---|
| Epilepsy surgeryEpilepsy surgery will be performed as a part of the clinical management of patients with drug-resistant epilepsy. | Procedure or surgery | Patients with epilepsy |
Primary outcome
Language outcome
Time frame: 1 year
Neuropsychological scores
1 secondary outcome
Seizure outcome
Time frame: 1 year
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 26 Feb 2025.
- Individual participant dataSharing planned: Yes. Following data de-identification, we propose to share our datasets with the public via 'NeuroElectroMagnetic Data Archive and Tools Resource (NEMAR)' or 'iEEG.org', both of which are NIH-funded data-sharing platforms.
Related trials for Epilepsy
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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.
Eishi Asano, MD, PhD principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epilepsy surgery in people with Epilepsy, run by Wayne State University at 2 sites 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Eishi Asano, MD, PhD (313-745-5563, easano@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language outcome (time frame: 1 year). 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 26 Feb 2025.