NCT00462566CompletedNot Applicable

The Efficacy of Motor Cortex Stimulation for Pain Control

Nova Scotia Health Authority1 site in 1 country12 target enrollmentStarted: October 1, 2005Last updated: October 18, 2016

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Nova Scotia Health Authority
Enrollment: 12
Locations: 1
Primary Endpoint: Global impression of change

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

Deafferentation facial pain,
Upper extremity complex regional pain syndrome (CRPS) and
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.

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:

Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
Neuropathic deafferentation facial pain
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:

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Single (Investigator)

Eligibility Criteria

Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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)
•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).

Outcomes