Spinal Magnetic Stimulation in Neuropathic Pain

• ClinicalTrials.gov Identifier: NCT00443469
• Recruitment Status: Completed
• First Posted: March 6, 2007
• Last Update Posted: March 31, 2010
• Sponsor: Singapore General Hospital
• Information provided by: Singapore General Hospital

Tracking Information

• First Submitted Date: March 4, 2007
• First Posted Date: March 6, 2007
• Last Update Posted Date: March 31, 2010
• Study Start Date: August 2006
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2010)

Subjective pain score measurements [ Time Frame: 4 days ]

NAS score

• Original Primary Outcome Measures (submitted: March 4, 2007): Subjective pain score measurements after SMS
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Spinal Magnetic Stimulation in Neuropathic Pain
• 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

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

• Detailed Description: You must be aware of that this is a placebo-controlled trial. This means that you may either receive real SMS or sham SMS. The latter involves a harmless process of ineffective stimulation, designed for comparison with real SMS. Whether you receive either form of treatment will be assigned randomly, and there will be a 50% chance of being assigned to either.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Neuropathic Pain

Intervention

• 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.

Study Arms

• Experimental: Magnetic Stimulation
  Intervention: Device: magnetic stimulation
• Placebo Comparator: Magnetic Stimulation with tilted coil
  Magnetic Stimulation with tilted coil
  Intervention: Device: Magnetic Stimulation with tilted coil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2010): 20
• Original Enrollment (submitted: March 4, 2007): 30
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All with neuropathic lower limb pain

Exclusion Criteria:

• Contraindications to magnetic stimulation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT00443469
• Other Study ID Numbers: #64/2006
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: A/Prof Lo YL, Singapore General Hospital, NNI
• Original Responsible Party: Not Provided
• Current Study Sponsor: Singapore General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: YL Lo, MD; National Neuroscience Institute, Singapore General Hospital

• PRS Account: Singapore General Hospital
• Verification Date: March 2010