Clinical trial NCT00462566: The Efficacy of Motor Cortex Stimulation for Pain Control
Official title: The Efficacy of Motor Cortex Stimulation for Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Phantom Limb Pain
Stump Pain
Brachial Plexus Avulsion
Deafferentation Pain
Facial Pain
Complex Regional Pain Syndrome
Keywords: Motor cortex stimulation
neuropathic
pain
complex regional pain syndrome
deafferentation facial pain
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2007-04-19
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
3. Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
4. Patients who are willing to provide informed consent.

Exclusion Criteria:

1. Patients who are not considered medically fit for neurosurgery.
2. Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
3. Patients who are not able to provide informed consent.
4. Patients unable to have magnetic resonance imaging (MRI).

Primary outcomes:
measure: Visual Analog scale
timeFrame: 1 month preop, at 12 and 24 weeks postop
measure: SF-36
timeFrame: 1 month preop, at 12 and 24 weeks postop
measure: McGill Pain questionnaire
timeFrame: 1 month preop, at 12 and 24 weeks postop
measure: Beck II depression
timeFrame: 1 month preop, at 12 and 24 weeks postop
measure: Global impression of change
timeFrame: at 12 and 24 weeks postop
measure: Medications log
timeFrame: 1 month preop, at 12 and 24 weeks postop
measure: Employment status
timeFrame: 1 month preop, at 12 and 24 weeks postop
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Dalhousie University, Queen Elizabeth II Health Sciences Centre
name: Robert M Brownstone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radic JA, Beauprie I, Chiasson P, Kiss ZH, Brownstone RM. Motor Cortex Stimulation for Neuropathic Pain: A Randomized Cross-over Trial. Can J Neurol Sci. 2015 Nov;42(6):401-9. doi: 10.1017/cjn.2015.292. Epub 2015 Sep 1.