Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2006-08-31
2010-02-28
Brief Summary
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You will be assessed before and after the study for up to 1 week. Your usual medical treatment will be continued
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Magnetic Stimulation
magnetic stimulation
SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.
Magnetic Stimulation with tilted coil
Magnetic Stimulation with tilted coil
Magnetic Stimulation with tilted coil
The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.
Interventions
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magnetic stimulation
SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.
Magnetic Stimulation with tilted coil
The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Singapore General Hospital, NNI
Principal Investigators
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YL Lo, MD
Role: PRINCIPAL_INVESTIGATOR
National Neuroscience Institute, Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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#64/2006
Identifier Type: -
Identifier Source: org_study_id