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NCT00453505 · ClinicalTrials.gov registry record · Early Phase 1
Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System
A Early Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 976
- Enrollment target
NCT00453505 is a Early Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 976 participants.
The verdict
NCT00453505, a Early Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 976 participants
- Enrollment target
Study Summary
Objectives When a stroke damages the part of the brain that controls movement, people have weakness and difficulty using their hand. There is often some improvement, but many people have permanent disability in using the affected hand. Our previous research has shown that if we stimulate the nerves or the brain, we can temporarily improve how fast people with and without strokes can move their hands. But improvement is very slight and doesn t last long. In this study, we are trying to see if different combinations of brain, skin and nerve stimulation might cause more improvement in motor function or learning. For this study, we will only include healthy people who have not had a stroke. We will use one or more types of electrical and magnetic stimulation of skin, nerves and the brain, or recording of behavior or brain activity alone without stimulation. Study Population Up to 1500 healthy volunteers, age 18 and older. What will volunteers do in this study Visits may include the following procedures: Electromyography (EMG) which measures electrical activity of muscles. Transcranial Magnetic Stimulation (TMS) where a wire coil is placed on the scalp, and brief electrical current creates a magnetic pulse that temporarily affect brain activity. This may feel like a pulling sensation where the coil is placed, and may result in twitches in the face, arm, or leg. Transcranial direct current stimulation (tDCS), a technique in which a very weak electrical current is applied to the head in order to stimulate the brain. Nerve Stimulation, where sticky pads or small metal disk electrodes attached to wires onto the skin to record muscle and nerve activity. Magnetic resonance imaging (MRI) which uses a strong magnetic field and radio waves to take pictures of the brain. Some MRIs the volunteers are asked to lie still, and in others are asked to do various movements. Magnetic resonance spectroscopy (MRS) uses a strong magnetic field and radio waves to take pictures of
Interventions
- DEVICE TMS
- DEVICE tACS
- DEVICE tDCS
- DEVICE CPNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 976 participants |
| Start Date | 2007-01-14 |
| Est. Completion | 2019-12-20 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00453505
The ClinicalTrials.gov registry entry for NCT00453505 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 976 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 4 interventions - of which TMS is the first listed.
NCT00453505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00453505 about?
NCT00453505 is a clinical study titled "Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System". Objectives When a stroke damages the part of the brain that controls movement, people have weakness and difficulty using their hand. There is often some improvement, but many people have permanent disability in using the affected hand. Our previous research has shown that if we stimulate the nerves...
What is the current status of trial NCT00453505?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 976 participants. The study started on 2007-01-14. Estimated completion is 2019-12-20.
What interventions are being tested in trial NCT00453505?
The interventions under investigation include: TMS (DEVICE), tACS (DEVICE), tDCS (DEVICE), CPNS (DEVICE).
Who is sponsoring clinical trial NCT00453505?
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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