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NCT01688570 · ClinicalTrials.gov registry record · Early Phase 1
Mechanisms of Neuromuscular Fatigue Post Stroke
A Early Phase 1 study of Stroke, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT01688570 is a Early Phase 1 study of Stroke that has completed, run by Medical College of Wisconsin. The registered enrollment target is 27 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01688570, a Early Phase 1 study of Stroke, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
While baseline weakness is clearly an important factor that contributes to disability post stroke, neuromuscular fatigue (the acute reduction in force production) of the paretic musculature likely compounds strength deficits and further exacerbates disability. The proposed study aims to improve our understanding of the mechanisms of neuromuscular fatigue in people post stroke in order to optimize strength training. In healthy individuals, both central (neural) and peripheral (muscle) factors are determinants of neuromuscular fatigue, but preliminary data from our laboratory suggests a greater contribution of central components to neuromuscular fatigue in the paretic musculature. Although cortical pathways are clearly disrupted post stroke, it is likely that brainstem pathways, known to have neuromodulatory effects on spinal motor circuitry, are more involved in the sustaining of force in the paretic leg, compared to the non-paretic and control legs. Therefore, the purpose of this proposal is to examine the role of descending neuromodulatory pathways of the brainstem in neuromuscular fatigue post stroke (Aim 1) and to correlate brainstem-related changes in neuromuscular fatigue to walking function (Aim 2). The investigators propose that stroke survivors' decreased capability to sustain force overtime results from the diminished ability of spinal motoneurons to respond to brainstem neuromodulatory inputs (serotonin (5-HT) and norepinephrine (NE)). Aim 1 will quantify stroke-related decreases in motor output sensitivity to a 5-HT and NE reuptake inhibitor (SNRI), serotonin antagonist, or placebo during sub-maximal intermittent fatiguing knee extension contractions. If motoneurons are desensitized to descending monoamines in chronic stroke patients, then they will be less sensitive to the effects of drugs that increase monoamine levels. The investigators predict that in response to the SNRI or serotonin antagonist, the paretic leg will show less change in time to task f
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cyproheptadine
- DRUG duloxetine
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-05 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01688570
The ClinicalTrials.gov registry entry for NCT01688570 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01688570 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01688570 about?
NCT01688570 is a clinical study titled "Mechanisms of Neuromuscular Fatigue Post Stroke". While baseline weakness is clearly an important factor that contributes to disability post stroke, neuromuscular fatigue (the acute reduction in force production) of the paretic musculature likely compounds strength deficits and further exacerbates disability. The proposed study aims to improve our ...
What is the current status of trial NCT01688570?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2011-08. Estimated completion is 2015-05.
What conditions does trial NCT01688570 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT01688570?
The interventions under investigation include: Placebo (DRUG), Cyproheptadine (DRUG), duloxetine (DRUG).
Who is sponsoring clinical trial NCT01688570?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01688570 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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