Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT00462566
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2007-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Motor Cortex Stimulation for Pain Control
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
The Efficacy of Motor Cortex Stimulation for Pain Control
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: