Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial
NCT05382832 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-05-19
Summary
The clinical trial is focused on the treatment of selected patients with a migraine after implantation of spinal cord stimulator (SCS) based on previous neurological examination. Patients will be randomized and divided into two groups. According to randomization patients will receive saline or botox into the epidural space. The efficacy of treatment will be compared and estimated in both groups during different SCS settings. Data will be collected in pre-set time frames.
Conditions
Interventions
- COMBINATION_PRODUCT
-
SCS
SCS-experimental treatment
- COMBINATION_PRODUCT
-
SCS
SCS-placebo
Sponsors & Collaborators
-
National Hospital for Neurology and Neurosurgery, London
collaborator UNKNOWN -
Europainclinics z.ú.
lead OTHER
Principal Investigators
-
Róbert Rapcan, MD, PhD, MBA, FIPP · EuroPainClincs
-
Ladislav Kočan, MD, PhD · EuroPainClincs
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2022-08-01
- Completion
- 2025-08-01
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