CompletedNot Applicable

The Efficacy of Motor Cortex Stimulation for Pain Control

Canada12 participantsStarted 2005-10

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis in one of the following three categories:
. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
. Patients who are willing to provide informed consent.

Exclusion criteria

. Patients who are not considered medically fit for neurosurgery.
. Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
. Patients who are not able to provide informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog scale

Timeframe: 1 month preop, at 12 and 24 weeks postop

SF-36

Timeframe: 1 month preop, at 12 and 24 weeks postop

McGill Pain questionnaire

Timeframe: 1 month preop, at 12 and 24 weeks postop

Beck II depression

Timeframe: 1 month preop, at 12 and 24 weeks postop

Global impression of change

Timeframe: at 12 and 24 weeks postop

Medications log

Timeframe: 1 month preop, at 12 and 24 weeks postop

Employment status

Timeframe: 1 month preop, at 12 and 24 weeks postop

Trial details

NCT IDNCT00462566

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-07

View on ClinicalTrials.gov More Neuropathic Pain trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis in one of the following three categories:
. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
. Patients who are willing to provide informed consent.

Exclusion criteria

. Patients who are not considered medically fit for neurosurgery.
. Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
. Patients who are not able to provide informed consent.

What they're measuring

Visual Analog scale

Timeframe: 1 month preop, at 12 and 24 weeks postop

SF-36

Timeframe: 1 month preop, at 12 and 24 weeks postop

McGill Pain questionnaire

Timeframe: 1 month preop, at 12 and 24 weeks postop

Beck II depression

Timeframe: 1 month preop, at 12 and 24 weeks postop

Global impression of change

Timeframe: at 12 and 24 weeks postop

Medications log

Timeframe: 1 month preop, at 12 and 24 weeks postop

Employment status

Timeframe: 1 month preop, at 12 and 24 weeks postop