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Clinical Trials/NCT05984329
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

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
May 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

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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