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Clinical Trials/NCT02465918
NCT02465918
Completed
Not Applicable

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

University of British Columbia1 site in 1 country6 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathic Pain
Sponsor
University of British Columbia
Enrollment
6
Locations
1
Primary Endpoint
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
July 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Honey

Associate Professor/Neurosurgeon

University of British Columbia

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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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