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NCT05984329 Clinical Trial

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

Neuropathic Pain Clinical Trial

Official title:
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05984329
Other study ID # IRBN872022/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2022
Est. completion date May 2024

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact François VASSAL, MD PhD
Phone (0)477127538
Email francois.vassal@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective analysis of patients' choice
Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.

Locations
Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of pain relief Percentage of analgesic relief compared with baseline (i.e. preoperative pain level) 6 months
Secondary Antalgic drugs intake Modification of pharmacological treatment doses (analgesics) 6 months
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