Neuropathic Pain Clinical Trial
Official title:
The Efficacy of Motor Cortex Stimulation for Pain Control
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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