Neuropathic PainPhase 3NCT00443469
Spinal Magnetic Stimulation in Neuropathic Pain
A Phase 3 study testing magnetic stimulation and Magnetic Stimulation with tilted coil in people with Neuropathic Pain, run by Singapore General Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- magnetic stimulation and Magnetic Stimulation with tilted coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2006to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All with neuropathic lower limb pain
Who cannot join
- Contraindications to magnetic stimulation
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- magnetic stimulation, Magnetic Stimulation with tilted coil
- Keywords
- magnetic stimulation, neuropathic pain, spinal, lower limb, clinical trial
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic stimulationDevice
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.
Magnetic Stimulation with tilted coilDevice
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 group | Role | What they receive |
|---|---|---|
| Magnetic Stimulation | Experimental | Not described Receives: Device: magnetic stimulation |
| Magnetic Stimulation with tilted coil | Placebo comparator | Magnetic Stimulation with tilted coil Receives: Device: Magnetic Stimulation with tilted coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain score measurements
NAS score
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startAug 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- YL Lo, MD, Principal investigator, National Neuroscience Institute, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443469
- Sponsor's protocol ID
- #64/2006
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2007
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00443469
- Acronym / sponsor ID
- #64/2006
- Conditions
- Neuropathic Pain
- Keywords
- magnetic stimulation, neuropathic pain, spinal, lower limb, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Stimulation | Experimental | Device: magnetic stimulation |
| Magnetic Stimulation with tilted coil | Placebo comparator | Device: Magnetic Stimulation with tilted coilMagnetic Stimulation with tilted coil |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All with neuropathic lower limb pain
Key exclusion criteria (1 listed)
- Contraindications to magnetic stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic stimulationSMS 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 |
| Magnetic Stimulation with tilted coilThe 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. | Device | Magnetic Stimulation with tilted coil |
Primary outcome
Subjective pain score measurements
Time frame: 4 days
NAS score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YL Lo, MD principal investigator
National Neuroscience Institute, Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnetic stimulation and Magnetic Stimulation with tilted coil in people with Neuropathic Pain, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain score measurements (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2010.