Clinical trial NCT02465918: Cyclization of Motor Cortex Stimulation
Official title: The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
timeFrame: At the End of each trial period, typically 14 days after change in stimulation settings
Secondary outcomes:
measure: Quality of Life assessment with the SF-36 questionnaire
timeFrame: At the end of each trial period, typically at 14 days after change in stimulation settings
Other outcomes:
measure: Pain assessment with the McGill pain questionnaire to record impact of pain
timeFrame: At the end of each trial period, typically 14 days after change in stimulation setting
Locations:
city: Vancouver
country: Canada
facility: The Vancouver General Hospital
state: British Columbia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.