NCT05984329
Completed
Not Applicable
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study
Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country14 target enrollmentJuly 15, 2022
ConditionsNeuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Percentage of pain relief
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.
Detailed Description
The main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for MCS with an internal pulse generator (IPG) capable of delivering both tonic and Burst DR(TM) stimulation waveforms.
Exclusion Criteria
- •Patients under 18 years old ; pregnancy
Outcomes
Primary Outcomes
Percentage of pain relief
Time Frame: 6 months
Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)
Secondary Outcomes
- Antalgic drugs intake(6 months)
Study Sites (1)
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