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Spinal Magnetic Stimulation in Neuropathic Pain

NCT00443469 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-03-31

No results posted yet for this study

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

Conditions

  • Neuropathic Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • YL Lo, MD · National Neuroscience Institute, Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443469 on ClinicalTrials.gov