Neuropathic Pain
Conditions
Brief summary
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.
Interventions
DEVICEmotor cortex stimulation (Change of Stimulation Timing)
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient more than 18 years of age * Chronic neuropathic pain effectively treated with motor cortex stimulation * Stable medication during the trial * Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.
Exclusion criteria
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator * Technical malfunction of the MCS device * History of seizures * Unable to provide informed consent
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Other
| Measure | 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 |
Countries
Canada
Outcome results
None listed