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Sponsored by: |
Capital District Health Authority, Canada |
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Information provided by: | Capital District Health Authority, Canada |
ClinicalTrials.gov Identifier: | NCT00462566 |
The objective is to determine if motor cortex stimulation works for the following conditions:
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 |
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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: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | The Efficacy of Motor Cortex Stimulation for Pain Control |
Estimated Enrollment: | 18 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | February 2008 |
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:
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis in one of the following three categories:
Exclusion Criteria:
Contact: Robert M Brownstone, MD, PhD | 902 473 6850 | rob.brownstone@dal.ca |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Contact: Robert M Brownstone, MD, PhD 902 473 6850 rob.brownstone@dal.ca | |
Contact: Paula M Chiasson, MSc 902 473 7809 paula.chiasson@cdha.nshealth.ca | |
Principal Investigator: Robert M Brownstone, MD, PhD |
Principal Investigator: | Robert M Brownstone, MD, PhD | Dalhousie University, Queen Elizabeth II Health Sciences Centre |
Study ID Numbers: | CDHA004 |
Study First Received: | April 17, 2007 |
Last Updated: | June 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00462566 |
Health Authority: | Canada: Health Canada |
Motor cortex stimulation neuropathic pain complex regional pain syndrome deafferentation facial pain |
Facial Pain Facies Neuralgia Pain Phantom Limb Signs and Symptoms Autonomic Nervous System Diseases |
Complex Regional Pain Syndromes Neuromuscular Diseases Peripheral Nervous System Diseases Causalgia Neurologic Manifestations Neurobehavioral Manifestations Perceptual Disorders |
Pathologic Processes Disease Syndrome Nervous System Diseases |