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Neuropathic PainNCT00462566

The Efficacy of Motor Cortex Stimulation for Pain Control

A study testing motor cortex stimulation in people with Neuropathic Pain and Phantom Limb Pain, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective is to determine if motor cortex stimulation works for the following conditions: 1. Deafferentation facial pain, 2. Upper extremity complex regional pain syndrome (CRPS) and 3. Brachial plexus avulsion or phantom limb pain. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neuropathic Pain, Phantom Limb Pain, Stump Pain
What is being tested?
motor cortex stimulation
Type of treatment
Medical device
How many people
12 participants
Where
1 siteCanada
Study dates
Oct 2005to Jul 2010
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis in one of the following three categories:
  • Unilateral upper extremity neuropathic pain such as phantom limb pain, stump pain or brachial plexus avulsion
  • Neuropathic deafferentation facial pain
  • Upper extremity complex regional pain syndrome (CRPS)
  • Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
  • Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
  • Patients who are willing to provide informed consent.

Who cannot join

  • Patients who are not considered medically fit for neurosurgery.
  • Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
  • Patients who are not able to provide informed consent.
  • Patients unable to have magnetic resonance imaging (MRI).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

Other trials in Canada

About this study

The objective is to determine if motor cortex stimulation works for the following conditions:

  1. Deafferentation facial pain,
  2. Upper extremity complex regional pain syndrome (CRPS) and
  3. Brachial plexus avulsion or phantom limb pain.

Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system. They will be randomised to either a regular or low stimulation setting in the two arms of the study. Each arm will last 3 months.

Read the detailed description

This is a prospective, blinded randomized crossover study comparing two stimulation paradigms in three different groups of patients receiving motor cortex stimulation. The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.

The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are:

  1. Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
  2. Neuropathic deafferentation facial pain
  3. Upper extremity complex regional pain syndrome (CRPS)

Measurements of the effects of motor cortex stimulation will include a visual analogue scale (VAS) of perceived pain, the McGill Pain Questionnaire, SF-36 quality of life questionnaire, Beck Depression Inventory-II, the standard 7-point patient global impression of change (PGIC), medications log (verified by pharmacy records) and an employment status questionnaire. Adverse events will be recorded at each visit.

Table 1:

Visit Study Week Standard Care 0a 1b 12c 24d 1a 2e 3f 4g F/Uh Clinic Visit X X X X X X Consent X Surgery X X X Program MCS X X X X X X VAS X X X X X X X SF-36 X X X X X X X Medications Log X X X X Employment Status X X X X McGill Pain X X X X X X X Beck Depression II X X X X Global impression of change X X

  1. Screening visit in consideration of MCS
  2. Immediate post-op visit, randomization to high or low settings
  3. 12 week crossover point
  4. Final study visit, MCS programmed at 'best' settings
  5. Trial period of MCS, lasting for 1 to 2 weeks
  6. Clinic visit to determine efficacy of MCS and removal of temporary external system.
  7. Permanent implantation of MCS, if trial was successful
  8. Follow-up as required.
Being tested
motor cortex stimulation
Keywords
Motor cortex stimulation, neuropathic, pain, complex regional pain syndrome, deafferentation facial pain
Medical subject headings
Neuralgia, Phantom Limb, Causalgia, Facial Pain, Complex Regional Pain Syndromes, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • motor cortex stimulationDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog scale

    Measured: 1 month preop, at 12 and 24 weeks postop

  2. SF-36

    Measured: 1 month preop, at 12 and 24 weeks postop

  3. McGill Pain questionnaire

    Measured: 1 month preop, at 12 and 24 weeks postop

  4. Beck II depression

    Measured: 1 month preop, at 12 and 24 weeks postop

  5. Global impression of change

    Measured: at 12 and 24 weeks postop

  6. Medications log

    Measured: 1 month preop, at 12 and 24 weeks postop

  7. Employment status

    Measured: 1 month preop, at 12 and 24 weeks postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462566
Sponsor's protocol ID
CDHA004
Status last verified
Jun 2016
First submitted
17 Apr 2007
Last updated
18 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Radic JA, Beauprie I, Chiasson P, Kiss ZH, Brownstone RM. Motor Cortex Stimulation for Neuropathic Pain: A Randomized Cross-over Trial. Can J Neurol Sci. 2015 Nov;42(6):401-9. doi: 10.1017/cjn.2015.292. Epub 2015 Sep 1.

    PubMed 26324857

Questions about this trial

What is this clinical trial studying?

A study testing motor cortex stimulation in people with Neuropathic Pain and Phantom Limb Pain, run by Nova Scotia Health Authority at 1 site in Canada.

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 7 inclusion and 4 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 18 Oct 2016. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Visual Analog scale (time frame: 1 month preop, at 12 and 24 weeks postop). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00462566, which also lists 1 linked publication.

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 18 Oct 2016.

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