The Efficacy of Motor Cortex Stimulation for Pain Control

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Completed

CT.gov ID

NCT00462566

Collaborator

Dalhousie University (Other)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain Phantom Limb Pain Stump Pain Brachial Plexus Avulsion Deafferentation Pain Facial Pain Complex Regional Pain Syndrome	Device: motor cortex stimulation	N/A

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:

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Motor Cortex Stimulation for Pain Control

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).