Cyclization of Motor Cortex Stimulation

Neuropathic Pain Clinical Trial

Official title:

The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465918
• Other study ID #: H15-01420
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• motor cortex stimulation (Change of Stimulation Timing)

Locations

Country	Name	City	State
Canada	The Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Review. — View Citation

Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguière F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-86. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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