Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial (BTX/SCS/TMig)
Migraine
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- migraine presence
Exclusion Criteria:
- disagreement with participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Placebo Comparator
A1 Group SCS
A1 Group Botox
B1 Group SCS
B1 Group Saline
A2 Group SCS
A2 Group Botox -after washout period
B2 Group SCS
B2 Group Saline -after washout period
Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant
Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant
Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant
Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant
Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation
Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation
Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation
Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation