Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01343537 · ClinicalTrials.gov registry record · Early Phase 1
Continuous Neurophysiological Monitoring Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects
A Early Phase 1 study, sponsored by State University of New York - Upstate Medical University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT01343537: Clinical Trial Early Phase 1 study, sponsored by State University of New York - Upstate Medical University.
NCT01343537 is a Early Phase 1 study that was terminated before completion, run by State University of New York - Upstate Medical University. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343537, a Early Phase 1 study, was terminated before completion, sponsored by State University of New York - Upstate Medical University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a serious condition with a high morbidity (incidence of having ill health) and mortality (death). There are approximately 11 cases per 100,000 in the population per year, and approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs after bleeding into the subarachnoid space, most commonly after aneurysmal rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which often results in a stroke. Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage. For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent deficits develop. There may be another option to solve this dilemma. The field of neuro-monitoring (neurological monitoring) has the technology available to continuously monitor brain activity of these sedated ICU subjects. This may allow for early diagnosis and possibly identify changes in neurologic function before they become symptomatic. In the past, neuro-monitoring was primarily used in the operating room to monitor neurologic function during surgery in and around the spinal cord. Surgery to the spine or spinal cord also carries its own form of risk, either from mechanical trauma to the spinal cord or its nerve roots, or from interruption of the blood supply to these structures. Should damage to nerve fibers occur, the end result could be paralysis, loss of sensation, and onset of severe burning (i.e. neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was developed to address these risks during spine surgery, whereby nerves rostral (toward the head) or caudal (toward the feet) to the site of surgery are stimulated (usua
Primary Outcome
To determine the feasibility and safety using intermittent motor evoked potentials, somatosensory evoked potentials and EEG monitoring to detect vasospasm compared against our standard detection methods including transcranial doppler ultrasound, computed tomography angiogram, computed tomography perfusion scan and the gold standard: formal cerebral angiography
Interventions
- OTHER Neuro Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-03 |
| Phase | Early Phase 1 |
Why NCT01343537 stopped before completion
NCT01343537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Neuro Monitoring is the first listed.
NCT01343537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343537 about?
NCT01343537 is a clinical study titled "Continuous Neurophysiological Monitoring Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects". Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a serious condition with a high morbidity (incidence of having ill health) and mortality (death). There are approximately 11 cases per 100,000 in the population per year, and approximately 40% of these cases are...
What is the current status of trial NCT01343537?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2010-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01343537?
The interventions under investigation include: Neuro Monitoring (OTHER).
Who is sponsoring clinical trial NCT01343537?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343537's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia