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NCT03584425 · ClinicalTrials.gov registry record · Early Phase 1
Imaging Laterality in Chronic Stroke Patients
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 44
- Enrollment target
NCT03584425: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT03584425 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 44 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03584425, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
In healthy individuals, unimanual movement (with either the left or right hand) is associated with activity in a network of predominantly contralateral brain regions, including the primary motor cortex (PMC). This laterality is often compromised following a middle cerebral artery (MCA) stroke. Neuroimaging studies of these patients have shown that unimanual movements with the effected hand are associated with elevated Blood Oxygen-Level Dependent (BOLD) signal in both the lesioned and the nonlesioned primary motor cortices. Elevated activity in the contralesional PMC is well-established in chronic stroke patients and is associated with poor motor rehabilitation outcomes. Yet the neurobiologic basis for this aberrant neural activity is equivocal. The overarching goal of this project is to determine the neurobiologic basis for elevated activity in the contralesional primary motor cortex.
Primary Outcome
Using spectroscopy investigators will determine if the ratio of glutamate/GABA is higher in stroke patients than controls. Furthermore, in healthy controls prepulse inhibition will be positively correlated with the concentration of GABA, and prepulse facilitation will be positively correlated with the concentration of glutamate. Although we expect this relationship to be true in both the controls and the stroke patients, variation from this pattern in the stroke patients would suggest that there
Interventions
- DIAGNOSTIC_TEST Rasch modified version of the Fugl-Meyer Motor assessment
- DIAGNOSTIC_TEST Anatomical image acquisition
- DIAGNOSTIC_TEST Functional MRI task and acquisition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-12-15 |
| Est. Completion | 2019-05-30 |
| Phase | Early Phase 1 |
What the finished NCT03584425 record still lists
NCT03584425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Rasch modified version of the Fugl-Meyer Motor assessment is the first listed.
NCT03584425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03584425 about?
NCT03584425 is a clinical study titled "Imaging Laterality in Chronic Stroke Patients". In healthy individuals, unimanual movement (with either the left or right hand) is associated with activity in a network of predominantly contralateral brain regions, including the primary motor cortex (PMC). This laterality is often compromised following a middle cerebral artery (MCA) stroke. Neuro...
What is the current status of trial NCT03584425?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 44 participants. The study started on 2014-12-15. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT03584425?
The interventions under investigation include: Rasch modified version of the Fugl-Meyer Motor assessment (DIAGNOSTIC_TEST), Anatomical image acquisition (DIAGNOSTIC_TEST), Functional MRI task and acquisition (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03584425?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03584425's enrollment target sits among peer trials
44 589th of 2000 higher than 1,402 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
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