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Motor Threshold and Motor Cortex Stimulation

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ClinicalTrials.gov Identifier: NCT02255643
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
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 parameters in patients already implanted with a motor cortex stimulation who have received good pain relief. The actual voltage may vary widely between patients but the investigators feel that there may be an "ideal" voltage if it is measured as a percentage of motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle contraction then a PMT = 80% would be a voltage that was eighty percent of that value. Although the actual voltage may be widely different between patients, the percentage needed may be very similar. The investigators therefore plan to measure the effect of different percentages of PMT in patients already being treated with motor cortex stimulation.

Systematic analysis of the findings of this study might help the individual participant and future patients to better programming and less side effects.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: Change of PMT setting Not Applicable

Detailed Description:

Motor cortex stimulation (MCS) is a form of brain stimulation for patients with medically refractory neuropathic pain. The strength of stimulation can be individually adjusted by changing the voltage of stimulation. Too high voltage will produce side effects (e.g. seizures) while too low voltage will not provide pain control. The aim of this study is to analyze the optimal stimulation parameters in patients already implanted with a motor cortex stimulation who have received good pain relief. The actual voltage may vary widely between patients (because of the individual variations in tissue resistance) but the investigators feel that there may be an "ideal" voltage if it is measured as a percentage of motor threshold (PMT).

If motor threshold is the voltage that can evoke a muscle contraction then a PMT = 80% would be a voltage that was eighty percent of that value. Although the actual voltage may be different between patients, the effective PMT may be similar since it represents a more physiologic measure of stimulation.

Systematic analysis of the findings of this study might help the individual participant and future patients by reducing voltage to the lowest effective setting and reducing the chance of seizures.

Motor cortex stimulation is used in the treatment of neuropathic pain since 1991 but still no guidelines for programming exist and programming is therefore mainly bases on trial and error. This is mostly due to many variables influencing the choice of stimulation parameters and significant individual differences in susceptibility to stimulation. Routinely the motor threshold is determined during programming to identify the superior limit of voltage at which twitching is induced. No stimulation above the motor threshold should be performed as this is known to cause seizures. The voltage of simulation that will be effective for an individual is unknown at the beginning of the treatment.

The investigators try to find the lowest effective voltage because that will reduce the risk of stimulation-induced seizures and prolong the life of the pacemaker.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Relationship Between Motor Threshold and Effective Stimulation Threshold During Motor Cortex Stimulation
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: -10% of effective PMT
Patients are set to a voltage 10% less than their original PMT at start of study, Changes in PMT settings
Device: Change of PMT setting
The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)

Active Comparator: former setting (+/- 0% of PMT)
Patients are set to their original PMT at start of study, Changes in PMT settings
Device: Change of PMT setting
The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)

Experimental: +10% of effective PMT
Patients are set to a voltage 10% more than their original PMT at start of study, Changes in PMT settings
Device: Change of PMT setting
The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)




Primary Outcome Measures :
  1. Change in Pain measured on the Visual Analogue Scale with different PMT Settings [ Time Frame: at the End of each trial period, typically 14 days after changes in PMT Settings ]

Secondary Outcome Measures :
  1. Quality of Life assessment with the SF-36 questionnaire [ Time Frame: at the end of each trial period, typically at 14 days ]

Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255643


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 4E3
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christopher R Honey, MD, DPhil UBC