NCT05984329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

August 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

August 2, 2023

Last Update Submit

August 22, 2024

Conditions

Neuropathic Pain

Keywords

Motor cortex stimulationneuropathic painBurst DR(TM) waveform

Outcome Measures

Primary Outcomes (1)

  • Percentage of pain relief

    Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)

    6 months

Secondary Outcomes (1)

  • Antalgic drugs intake

    6 months

Study Arms (2)

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

Burst DR(TM) then tonic

Burst DR(TM) MCS for 3 months then tonic MCS for 3 months

Other: Retrospective analysis of patients' choice

Interventions

Retrospective analysis of patients' choiceOTHER

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

Burst DR(TM) then tonicTonic then Burst DR(TM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MCS patients.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years old ; pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • François VASSAL, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 9, 2023

Study Start

July 15, 2022

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

August 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)