Spinal Magnetic Stimulation in Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT00443469|
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : March 31, 2010
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
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Device: magnetic stimulation Device: Magnetic Stimulation with tilted coil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||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|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Experimental: Magnetic Stimulation||
Device: 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.
Placebo Comparator: Magnetic Stimulation with tilted coil
Magnetic Stimulation with tilted coil
Device: 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.
- Subjective pain score measurements [ Time Frame: 4 days ]NAS score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443469
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||YL Lo, MD||National Neuroscience Institute, Singapore General Hospital|