A Phase 1 interventional study of Repetitive Transcranial Magnetic Stimulation in Stroke, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by US Department of Veterans Affairs · Phase 1, Interventional, and Treatment
We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.
This case series assesses the effects of five consecutive days of low-frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) with and without a 6-Hz primer. Although this paper studies able-bodied individuals, similar rTMS protocols are used to facilitate motor recovery in patients with hemiplegia following stroke. However, the cortical mechanisms associated with repeated daily doses of rTMS are not completely understood.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 4 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Receive 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
Receive 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Also known as: RTMS
Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .
Time frame: Baseline (day 0) and 2 weeks
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .
| percentage change of BOLD | Number of Participants Who Received Primed rTMS | Number of Participants Who Received Unprimed rTMS |
|---|---|---|
| Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks | 3 ± .5 | 2 ± .25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 0/2 (0%) | 0/2 (0%) |
| Arm 2 | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs