The Efficacy of Motor Cortex Stimulation for Pain Control

October 17, 2016 updated by: Nova Scotia Health Authority

The objective is to determine if motor cortex stimulation works for the following conditions:

  1. Deafferentation facial pain,
  2. Upper extremity complex regional pain syndrome (CRPS) and
  3. Brachial plexus avulsion or phantom limb pain.

Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system. They will be randomised to either a regular or low stimulation setting in the two arms of the study. Each arm will last 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, blinded randomized crossover study comparing two stimulation paradigms in three different groups of patients receiving motor cortex stimulation. The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.

The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are:

  1. Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
  2. Neuropathic deafferentation facial pain
  3. Upper extremity complex regional pain syndrome (CRPS)

Measurements of the effects of motor cortex stimulation will include a visual analogue scale (VAS) of perceived pain, the McGill Pain Questionnaire, SF-36 quality of life questionnaire, Beck Depression Inventory-II, the standard 7-point patient global impression of change (PGIC), medications log (verified by pharmacy records) and an employment status questionnaire. Adverse events will be recorded at each visit.

Table 1:

Visit Study Week Standard Care 0a 1b 12c 24d 1a 2e 3f 4g F/Uh Clinic Visit X X X X X X Consent X Surgery X X X Program MCS X X X X X X VAS X X X X X X X SF-36 X X X X X X X Medications Log X X X X Employment Status X X X X McGill Pain X X X X X X X Beck Depression II X X X X Global impression of change X X

  1. Screening visit in consideration of MCS
  2. Immediate post-op visit, randomization to high or low settings
  3. 12 week crossover point
  4. Final study visit, MCS programmed at 'best' settings
  5. Trial period of MCS, lasting for 1 to 2 weeks
  6. Clinic visit to determine efficacy of MCS and removal of temporary external system.
  7. Permanent implantation of MCS, if trial was successful
  8. Follow-up as required.

Study Type

Interventional

Enrollment (Actual)

12

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
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth Ii Health Sciences Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis in one of the following three categories:

    • Unilateral upper extremity neuropathic pain such as phantom limb pain, stump pain or brachial plexus avulsion
    • Neuropathic deafferentation facial pain
    • Upper extremity complex regional pain syndrome (CRPS)
  2. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
  3. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
  4. Patients who are willing to provide informed consent.

Exclusion Criteria:

  1. Patients who are not considered medically fit for neurosurgery.
  2. Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
  3. Patients who are not able to provide informed consent.
  4. Patients unable to have magnetic resonance imaging (MRI).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog scale
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop
SF-36
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop
McGill Pain questionnaire
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop
Beck II depression
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop
Global impression of change
Time Frame: at 12 and 24 weeks postop
at 12 and 24 weeks postop
Medications log
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop
Employment status
Time Frame: 1 month preop, at 12 and 24 weeks postop
1 month preop, at 12 and 24 weeks postop

Collaborators and Investigators

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

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Robert M Brownstone, MD, PhD, Dalhousie University, Queen Elizabeth II Health Sciences Centre

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

October 1, 2005

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA004

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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