The Efficacy of Motor Cortex Stimulation for Pain Control

Neuropathic Pain Clinical Trial

Official title: The Efficacy of Motor Cortex Stimulation for Pain Control

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brachial Plexus Avulsion
• Causalgia
• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Deafferentation Pain
• Facial Pain
• Neuralgia
• Neuropathic Pain
• Phantom Limb
• Phantom Limb Pain
• Reflex Sympathetic Dystrophy
• Stump Pain

• NCT number: NCT00462566
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Completion date: July 2010