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The Efficacy of Motor Cortex Stimulation for Pain Control
This study has been completed.

First Received on April 17, 2007.   Last Updated on September 8, 2010   History of Changes
Sponsor: Capital District Health Authority, Canada
Information provided by: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00462566
  Purpose

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 Intervention
Neuropathic Pain
Phantom Limb Pain
Stump Pain
Brachial Plexus Avulsion
Deafferentation Pain
Facial Pain
Complex Regional Pain Syndrome
 Device: motor cortex stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Motor Cortex Stimulation for Pain Control

Resource links provided by NLM:

MedlinePlus related topics: Complex Regional Pain Syndrome
U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Visual Analog scale [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • McGill Pain questionnaire [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • Beck II depression [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • Global impression of change [ Time Frame: at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • Medications log [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]
  • Employment status [ Time Frame: 1 month preop, at 12 and 24 weeks postop ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462566

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

No publications provided

Responsible Party: Dr. Rob Brownstone, Dalhousie University
ClinicalTrials.gov Identifier: NCT00462566     History of Changes
Other Study ID Numbers: CDHA004
Study First Received: April 17, 2007
Last Updated: September 8, 2010
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Motor cortex stimulation
neuropathic
pain
complex regional pain syndrome
deafferentation facial pain

Additional relevant MeSH terms:
Causalgia
Facial Pain
Neuralgia
Phantom Limb
Somatoform Disorders
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012



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