The Efficacy of Motor Cortex Stimulation for Pain Control
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.
Phantom Limb Pain
Brachial Plexus Avulsion
Complex Regional Pain Syndrome
Device: motor cortex stimulation
|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|
- 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 ]
|Study Start Date:||October 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
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.
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Robert M Brownstone, MD, PhD||Dalhousie University, Queen Elizabeth II Health Sciences Centre|