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NCT00072735 · ClinicalTrials.gov registry record · Phase 1
Improvement of Use Dependent Plasticity in Chronic Stroke Patients
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00072735 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 48 participants.
The verdict
NCT00072735, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will examine the role of an amphetamine in improving the effect that electrical nerve stimulation has over brain flexibility associated with motor training in patients who experienced a stroke more than 1 year before. Chronic stroke is the main cause of long-term disability among adults. Previous studies have shown that electrical stimulation given over the skin may improve patients' recovery of motor function. Furthermore, it is known that amphetamines can improve the effects of sensory stimulation such as touch. Use dependent plasticity refers to a process in which the performance of simple, repetitive finger movements leads to encoding the details of those actions in the primary motor cortex of the brain. Plasticity in this sense refers to the capacity for change in the brain. Patients 18 years of age and older who have had a stroke, who have no history of other neurological and psychiatric illnesses, and who are able to contrite and perform simple attentional tasks and other tasks may be eligible for this study. There will also be healthy participants as a control group. Participants will have an electrocardiogram. They will also go through a practice session of about 3 hours in which they become familiar with the different tasks required in the study: motor training, pinch force, and the Jebsen-Taylor Test-which requires doing as fast as possible actions that include writing, lifting small common objects, turning pages, or lifting light or heavy objects. Then during the study, patients will be involved in a variety of sessions: * Motor training alone for about 3 hours. * Motor training, amphetamine (or placebo), and electrical stimulation for about 6 hours. * Motor training, amphetamine, and no electrical stimulation for about 6 hours. A magnetic resonance imagining (MRI) scan will be done. Patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes t
Interventions
- PROCEDURE Electrocardiogram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2003-11-06 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00072735
The ClinicalTrials.gov registry entry for NCT00072735 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Electrocardiogram is the first listed.
NCT00072735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00072735 about?
NCT00072735 is a clinical study titled "Improvement of Use Dependent Plasticity in Chronic Stroke Patients". This study will examine the role of an amphetamine in improving the effect that electrical nerve stimulation has over brain flexibility associated with motor training in patients who experienced a stroke more than 1 year before. Chronic stroke is the main cause of long-term disability among adults. ...
What is the current status of trial NCT00072735?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2003-11-06. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00072735?
The interventions under investigation include: Electrocardiogram (PROCEDURE).
Who is sponsoring clinical trial NCT00072735?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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