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NCT04649008 · ClinicalTrials.gov registry record · Early Phase 1
Localizing Epileptic Networks Using MRI and iEEG
A Early Phase 1 study of Epilepsy and Epilepsy, Temporal Lobe, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 290
- Enrollment target
- 1
- Study location
NCT04649008: Recruiting Early Phase 1 study of Epilepsy and Epilepsy, Temporal Lobe, sponsored by University of Pennsylvania.
NCT04649008 is a Early Phase 1 study of Epilepsy and Epilepsy, Temporal Lobe that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 290 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04649008, a Early Phase 1 study of Epilepsy and Epilepsy, Temporal Lobe, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 290 participants
- Enrollment target
- 1
- Study location
Study Summary
Upon successful completion of this study, the investigators expect the study's contribution to be the development of noninvasive imaging biomarkers to predict IEEG functional dynamics and epilepsy surgical outcomes. Findings from the present study may inform current and new therapies to map and alter seizure spread, and pave the way for less invasive, better- targeted, patient-specific interventions with improved surgical outcomes. This research is relevant to public health because over 20 million people worldwide suffer from focal drug-resistant epilepsy and are potential candidates for cure with epilepsy surgical interventions.
Primary Outcome
This study aims to analyze MRI and iEEG to quantify structure-function coupling (SC-FC), specifically between white matter connections and IEEG, across preictal and ictal periods in consecutive patients undergoing IEEG monitoring with SEEG targeting the temporal lobe networks at the University of Pennsylvania and Medical University of South Carolina.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 3T Magnetic Resonance Imaging
- DIAGNOSTIC_TEST Intracranial electroencephalography recordings
- DIAGNOSTIC_TEST 7T Magnetic Resonance Imaging
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2027-02-28 |
| Phase | Early Phase 1 |
What NCT04649008 shows while recruiting
NCT04649008 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Epilepsy appearing as the primary indexed condition, and to 3 interventions - of which 3T Magnetic Resonance Imaging is the first listed.
NCT04649008 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04649008 about?
NCT04649008 is a clinical study titled "Localizing Epileptic Networks Using MRI and iEEG". Upon successful completion of this study, the investigators expect the study's contribution to be the development of noninvasive imaging biomarkers to predict IEEG functional dynamics and epilepsy surgical outcomes. Findings from the present study may inform current and new therapies to map and alte...
What is the current status of trial NCT04649008?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 290 participants. The study started on 2021-03-01. Estimated completion is 2027-02-28.
What conditions does trial NCT04649008 study?
This clinical trial studies the following conditions: Epilepsy, Epilepsy, Temporal Lobe, Epilepsy Intractable.
What interventions are being tested in trial NCT04649008?
The interventions under investigation include: 3T Magnetic Resonance Imaging (DIAGNOSTIC_TEST), Intracranial electroencephalography recordings (DIAGNOSTIC_TEST), 7T Magnetic Resonance Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04649008?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04649008 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04649008's enrollment target sits among peer trials
290 23rd of 160 higher than 138 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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