Neuropathic PainNCT05984329
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain
An observational study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Retrospective analysis of patients' choice
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2022to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MCS patients.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years old ; pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Retrospective analysis of patients' choice
- Keywords
- Motor cortex stimulation, neuropathic pain, Burst DR(TM) waveform
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of patients' choiceOther
Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.
| Study group | Role | What they receive |
|---|---|---|
| Tonic then Burst DR(TM) | Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months Receives: Other: Retrospective analysis of patients' choice | |
| Burst DR(TM) then tonic | Burst DR(TM) MCS for 3 months then tonic MCS for 3 months Receives: Other: Retrospective analysis of patients' choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pain relief
Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)
Measured: 6 months
Secondary outcomes (1)
Antalgic drugs intake
Modification of pharmacological treatment doses (analgesics)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Jul 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François VASSAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984329
- Sponsor's protocol ID
- IRBN872022/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study
- ClinicalTrials.gov ID
- NCT05984329
- Acronym / sponsor ID
- IRBN872022/CHUSTE
- Conditions
- Neuropathic Pain
- Keywords
- Motor cortex stimulation, neuropathic pain, Burst DR(TM) waveform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tonic then Burst DR(TM) | – | Other: Retrospective analysis of patients' choiceTonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months |
| Burst DR(TM) then tonic | – | Other: Retrospective analysis of patients' choiceBurst DR(TM) MCS for 3 months then tonic MCS for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MCS patients.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under 18 years old ; pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective analysis of patients' choiceRetrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect. | Other | Burst DR(TM) then tonic, Tonic then Burst DR(TM) |
Primary outcome
Percentage of pain relief
Time frame: 6 months
Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)
1 secondary outcome
Antalgic drugs intake
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François VASSAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pain relief (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.