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The Efficacy of Motor Cortex Stimulation for Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462566
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : October 18, 2016
Dalhousie University
Information provided by (Responsible Party):
Nova Scotia Health Authority

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Phantom Limb Pain Stump Pain Brachial Plexus Avulsion Deafferentation Pain Facial Pain Complex Regional Pain Syndrome Device: motor cortex stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Motor Cortex Stimulation for Pain Control
Study Start Date : October 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Visual Analog scale [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]
  2. SF-36 [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]
  3. McGill Pain questionnaire [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]
  4. Beck II depression [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]
  5. Global impression of change [ Time Frame: at 12 and 24 weeks postop ]
  6. Medications log [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]
  7. Employment status [ Time Frame: 1 month preop, at 12 and 24 weeks postop ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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)
  2. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
  3. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
  4. Patients who are willing to provide informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462566

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Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Nova Scotia Health Authority
Dalhousie University
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Principal Investigator: Robert M Brownstone, MD, PhD Dalhousie University, Queen Elizabeth II Health Sciences Centre

Publications of Results:
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Responsible Party: Nova Scotia Health Authority Identifier: NCT00462566     History of Changes
Other Study ID Numbers: CDHA004
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: June 2016

Keywords provided by Nova Scotia Health Authority:
Motor cortex stimulation
complex regional pain syndrome
deafferentation facial pain

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Phantom Limb
Facial Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes