Skip to main content
OpenTrials
Completed

NCT Number: NCT02465918

Cyclization of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motor cortex stimulation (Change of Stimulation Timing)

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.