The Efficacy of Motor Cortex Stimulation for Pain Control
Primary Purpose
Neuropathic Pain, Phantom Limb Pain, Stump Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
motor cortex stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Motor cortex stimulation, neuropathic, pain, complex regional pain syndrome, deafferentation facial pain
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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).
Sites / Locations
- Queen Elizabeth II Health Sciences Centre
Outcomes
Primary Outcome Measures
Visual Analog scale
SF-36
McGill Pain questionnaire
Beck II depression
Global impression of change
Medications log
Employment status
Secondary Outcome Measures
Full Information
NCT ID
NCT00462566
First Posted
April 17, 2007
Last Updated
October 17, 2016
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
1. Study Identification
Unique Protocol Identification Number
NCT00462566
Brief Title
The Efficacy of Motor Cortex Stimulation for Pain Control
Official Title
The Efficacy of Motor Cortex Stimulation for Pain Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to determine if motor cortex stimulation works for the following conditions:
Deafferentation facial pain,
Upper extremity complex regional pain syndrome (CRPS) and
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.
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:
Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
Neuropathic deafferentation facial pain
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
Screening visit in consideration of MCS
Immediate post-op visit, randomization to high or low settings
12 week crossover point
Final study visit, MCS programmed at 'best' settings
Trial period of MCS, lasting for 1 to 2 weeks
Clinic visit to determine efficacy of MCS and removal of temporary external system.
Permanent implantation of MCS, if trial was successful
Follow-up as required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Phantom Limb Pain, Stump Pain, Brachial Plexus Avulsion, Deafferentation Pain, Facial Pain, Complex Regional Pain Syndrome
Keywords
Motor cortex stimulation, neuropathic, pain, complex regional pain syndrome, deafferentation facial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
motor cortex stimulation
Primary Outcome Measure Information:
Title
Visual Analog scale
Time Frame
1 month preop, at 12 and 24 weeks postop
Title
SF-36
Time Frame
1 month preop, at 12 and 24 weeks postop
Title
McGill Pain questionnaire
Time Frame
1 month preop, at 12 and 24 weeks postop
Title
Beck II depression
Time Frame
1 month preop, at 12 and 24 weeks postop
Title
Global impression of change
Time Frame
at 12 and 24 weeks postop
Title
Medications log
Time Frame
1 month preop, at 12 and 24 weeks postop
Title
Employment status
Time Frame
1 month preop, at 12 and 24 weeks postop
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Brownstone, MD, PhD
Organizational Affiliation
Dalhousie University, Queen Elizabeth II Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26324857
Citation
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.
Results Reference
result
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The Efficacy of Motor Cortex Stimulation for Pain Control
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