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NCT01751854 · ClinicalTrials.gov registry record · Phase 1
Enhanced Motor Recovery Using Serotonergic Agents in Stroke
A Phase 1 study, sponsored by Shirley Ryan AbilityLab.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01751854 is a Phase 1 study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 30 participants.
The verdict
NCT01751854, a Phase 1 study, has completed, sponsored by Shirley Ryan AbilityLab.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to: 1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis, 2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.
Interventions
- DRUG Placebo
- DRUG SSRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-12 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01751854
The ClinicalTrials.gov registry entry for NCT01751854 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01751854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01751854 about?
NCT01751854 is a clinical study titled "Enhanced Motor Recovery Using Serotonergic Agents in Stroke". The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neu...
What is the current status of trial NCT01751854?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-12. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01751854?
The interventions under investigation include: Placebo (DRUG), SSRI (DRUG).
Who is sponsoring clinical trial NCT01751854?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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