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

SexALL

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.
✕. Patients unable to have magnetic resonance imaging (MRI).

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

SexALL

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.
✕. Patients unable to have magnetic resonance imaging (MRI).

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