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Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.
The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.
The aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Original Setting- MCS 30 min off/0 min off | Active Comparator | Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour. |
|
| MCS 25 min on/5 min off | Experimental | Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour. |
|
| MCS 20 min on/10 min off | Experimental | Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour. |
|
| MCS 15 min on/15 min off | Experimental | Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motor cortex stimulation (Change of Stimulation Timing) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings | At the End of each trial period, typically 14 days after change in stimulation settings |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life assessment with the SF-36 questionnaire | At the end of each trial period, typically at 14 days after change in stimulation settings |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment with the McGill pain questionnaire to record impact of pain | At the end of each trial period, typically 14 days after change in stimulation setting |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vancouver General Hospital | Vancouver | British Columbia | V5Z 4E3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1705329 | Result | Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x. | |
| 1792954 | Result | Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| 8657427 | Result | Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V. |
| 18541887 | Result | Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |