Spinal Magnetic Stimulation in Neuropathic Pain - Full Text View

Purpose

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	Intervention	Phase
Neuropathic Pain	Device: magnetic stimulation Device: Magnetic Stimulation with tilted coil	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
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

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:

Subjective pain score measurements [ Time Frame: 4 days ] [ Designated as safety issue: No ]
NAS score

Enrollment:	20
Study Start Date:	August 2006
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All with neuropathic lower limb pain

Exclusion Criteria:

Contraindications to magnetic stimulation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443469

Locations

Singapore
Singapore General Hospital
Singapore, Singapore, 169608

Sponsors and Collaborators

Singapore General Hospital

Investigators

Principal Investigator:

YL Lo, MD

National Neuroscience Institute, Singapore General Hospital

More Information

No publications provided

Responsible Party:	A/Prof Lo YL, Singapore General Hospital, NNI
ClinicalTrials.gov Identifier:	NCT00443469 History of Changes
Other Study ID Numbers:	#64/2006
Study First Received:	March 4, 2007
Last Updated:	March 30, 2010
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:

magnetic stimulation
neuropathic pain
spinal
lower limb
clinical trial

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases

Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013