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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: Retrospective analysis of patients' choice

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: François VASSAL, MD PhD; Phone Number: +33 (0)477127538; Email: francois.vassal@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Recruiting
    • CHU Saint-Etienne
    • Contact: François VASSAL, MD PhD; Phone Number: +33 (0)477127538; Email: francois.vassal@chu-st-etienne.fr
    • Principal Investigator: François VASSAL, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MCS patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tonic then Burst DR(TM); Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months	Other: Retrospective analysis of patients' choice; Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.
Burst DR(TM) then tonic; Burst DR(TM) MCS for 3 months then tonic MCS for 3 months	Other: Retrospective analysis of patients' choice; Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of pain relief	Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antalgic drugs intake	Modification of pharmacological treatment doses (analgesics)	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: François VASSAL, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: neuropathic pain; Motor cortex stimulation; Burst DR(TM) waveform
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: IRBN872022/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No