Cyclization of Motor Cortex Stimulation

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Device: motor cortex stimulation (Change of Stimulation Timing)

• Registration Number: NCT02465918
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Study Start: 2015-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Original Setting- MCS 30 min off/0 min off	motor cortex stimulation (Change of Stimulation Timing)	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	motor cortex stimulation (Change of Stimulation Timing)	Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour.
MCS 15 min on/15 min off	motor cortex stimulation (Change of Stimulation Timing)	Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour.
MCS 20 min on/10 min off	motor cortex stimulation (Change of Stimulation Timing)	Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada