Neuropathic Pain Clinical Trial
Official title:
The Efficacy of Motor Cortex Stimulation for Pain Control
Verified date | June 2016 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. 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) 2. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician 3. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery 4. Patients who are willing to provide informed consent. Exclusion Criteria: 1. Patients who are not considered medically fit for neurosurgery. 2. Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation. 3. Patients who are not able to provide informed consent. 4. Patients unable to have magnetic resonance imaging (MRI). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority | Dalhousie University |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog scale | 1 month preop, at 12 and 24 weeks postop | No | |
Primary | SF-36 | 1 month preop, at 12 and 24 weeks postop | No | |
Primary | McGill Pain questionnaire | 1 month preop, at 12 and 24 weeks postop | No | |
Primary | Beck II depression | 1 month preop, at 12 and 24 weeks postop | No | |
Primary | Global impression of change | at 12 and 24 weeks postop | No | |
Primary | Medications log | 1 month preop, at 12 and 24 weeks postop | No | |
Primary | Employment status | 1 month preop, at 12 and 24 weeks postop | No |
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