Spinal Magnetic Stimulation in Neuropathic Pain
A Randomized Placebo-controlled Trial on the Use of Repetitive Spinal Magnetic Stimulation as a Therapeutic Option in Patients With Intractable Neuropathic Pain of the Lower Limbs
1 other identifier
interventional
20
1 country
1
Brief Summary
It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the present study, we are using the same method to treat severe pain due to nerve conditions. You will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given over the head. You will be assessed before and after the study for up to 1 week. Your usual medical treatment will be continued
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 4, 2007
CompletedFirst Posted
Study publicly available on registry
March 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 31, 2010
March 1, 2010
3.5 years
March 4, 2007
March 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective pain score measurements
NAS score
4 days
Study Arms (2)
Magnetic Stimulation
EXPERIMENTALMagnetic Stimulation with tilted coil
PLACEBO COMPARATORMagnetic Stimulation with tilted coil
Interventions
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.
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
You may qualify if:
- All with neuropathic lower limb pain
You may not qualify if:
- Contraindications to magnetic stimulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore General Hospital
Singapore, 169608, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YL Lo, MD
National Neuroscience Institute, Singapore General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 4, 2007
First Posted
March 6, 2007
Study Start
August 1, 2006
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 31, 2010
Record last verified: 2010-03