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NCT04897776 · ClinicalTrials.gov registry record · NA
Stimulation of the Thalamus for Arousal Restoral in Temporal Lobe Epilepsy
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04897776: Completed NA study, sponsored by Yale University.
NCT04897776 is a NA study that has completed, run by Yale University. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897776, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The goal is to provide a novel therapeutic option for temporal lobe epilepsy patients when focal impaired awareness seizures cannot be stopped by medications, surgical or laser ablation, or by neurostimulation. The goal is restore consciousness when seizures cannot be stopped. If successful, addition of bilateral thalamic stimulation to existing responsive neurostimulation to rescue consciousness would greatly alter clinical practice and patient outcomes. Importantly, previous approaches aim to stop seizures, whereas this study aims to use thalamic stimulation to improve a major negative consequence when seizures cannot be stopped. The potential impact extends beyond temporal lobe epilepsy to other seizure types, and may also extend more broadly to inform treatment of other brain disorders associated with impaired consciousness and cognition.
Primary Outcome
Evaluate levels of conscious awareness during and following seizures, based on a behavioral responsiveness scale. Behavioral responsiveness is delivered on a tablet device automatically when a seizure is identified by the neurostimulator device. Automatic Responsiveness Testing in Epilepsy has a score range of 0 to 18, where 0 is not consciousness and/or unable to interact appropriately to commands and 18 is conscious, aware, and able to interact appropriately to commands. This is measured at sc
Interventions
- DEVICE Central Thalamic Stimulation
- DEVICE Hippocampal Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-10-31 |
| Est. Completion | 2025-07-15 |
| Phase | NA |
What the finished NCT04897776 record still lists
NCT04897776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Central Thalamic Stimulation is the first listed.
NCT04897776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04897776 about?
NCT04897776 is a clinical study titled "Stimulation of the Thalamus for Arousal Restoral in Temporal Lobe Epilepsy". The goal is to provide a novel therapeutic option for temporal lobe epilepsy patients when focal impaired awareness seizures cannot be stopped by medications, surgical or laser ablation, or by neurostimulation. The goal is restore consciousness when seizures cannot be stopped. If successful, additio...
What is the current status of trial NCT04897776?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2021-10-31. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT04897776?
The interventions under investigation include: Central Thalamic Stimulation (DEVICE), Hippocampal Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04897776?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04897776's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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