Dear Debbie -
Looks like we missed the boat, at least for now. Running a search through ClinicalTrials.gov - maintained by the NIH at
http://www.clinicaltrials.gov/ct2/home - as well as the WHO's International Clinical Trials Registry Platform (ICTRP)
http://www.who.int/ictrp/en/ shows only a single study on point
The Efficacy of Motor Cortex Stimulation for Pain Control, under the direction of Robert M. Brownstone, MD, PhD, a neurosurgeon at the Neuroscience Institute, Dalhousie University, Halifax, Nova Scotia, who has some 38 highly sophisticated neuroscience and neurosurgery articles coming up on PubMed, many of which are freely downloadable. And that study apparently completed its final data collection in July, 2010. So publication is hopefully imminent.
And the "Detailed Description" of the study is encouraging:
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. . . . [Emphasis added.]
http://www.clinicaltrials.gov/ct2/sh...0462566&rank=1
http://www.nhs.uk/Conditions/Complex...n=5&Rec=0&CT=0
I suppose what really gets my attention is that researchers are now calibrating dosages!
Mike