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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05984329
Enrollment
14
Registered
2023-08-09
Start date
2022-07-15
Completion date
2024-05-15
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Keywords

Motor cortex stimulation, neuropathic pain, Burst DR(TM) waveform

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.

Interventions

OTHERRetrospective analysis of patients' choice

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of pain relief6 monthsPercentage of analgesic relief compared with baseline (i.e. preoperative pain level)

Secondary

MeasureTime frameDescription
Antalgic drugs intake6 monthsModification of pharmacological treatment doses (analgesics)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026