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

NCT ID: NCT05984329

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuropathic Pain

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tonic then Burst DR(TM)

Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months

Retrospective analysis of patients' choice

Intervention Type OTHER

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

Retrospective analysis of patients' choice

Intervention Type OTHER

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

Interventions

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Retrospective analysis of patients' choice

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François VASSAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN872022/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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