Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain

Completed

• Conditions: Neuropathic Pain

• Registration Number: NCT05984329
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of pain relief	6 months	Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)

Secondary Outcome Measures

Name	Time	Method
Antalgic drugs intake	6 months	Modification of pharmacological treatment doses (analgesics)

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France