Cyclization of Motor Cortex Stimulation

October 29, 2020 updated by: Christopher Honey, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • The Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Original Setting- MCS 30 min off/0 min off
Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour.
Device: motor cortex stimulation (Change of Stimulation Timing)
Experimental: MCS 25 min on/5 min off
Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour.
Device: motor cortex stimulation (Change of Stimulation Timing)
Experimental: MCS 20 min on/10 min off
Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour.
Device: motor cortex stimulation (Change of Stimulation Timing)
Experimental: MCS 15 min on/15 min off
Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour.
Device: motor cortex stimulation (Change of Stimulation Timing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
Time Frame: At the End of each trial period, typically 14 days after change in stimulation settings
At the End of each trial period, typically 14 days after change in stimulation settings

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life assessment with the SF-36 questionnaire
Time Frame: At the end of each trial period, typically at 14 days after change in stimulation settings
At the end of each trial period, typically at 14 days after change in stimulation settings

Other Outcome Measures

Outcome Measure
Time Frame
Pain assessment with the McGill pain questionnaire to record impact of pain
Time Frame: At the end of each trial period, typically 14 days after change in stimulation setting
At the end of each trial period, typically 14 days after change in stimulation setting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-01420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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