Neuropathic Pain RebelPhase 4NCT00241566
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
A Phase 4 study testing implantation of stimulator in people with Neuropathic Pain Rebel, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain Rebel
- What is being tested?
- implantation of stimulator
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- Aug 2003to Dec 2007
- Phase
- Phase 4
- 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
Who may be able to join
- Presence of pain caused by lesion of central or peripheral nervous system
- Pain persistent since one year at least
- Pain untreated with 3 different antalgic treatments
Who cannot join
- Pain linked t a malignant affection
- patient < 18 years-old
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clermont-Ferrand UH
Clermont-Ferrand, Auvergne, 63003
Neurosurgery - Henri Mondor Hospital
Créteil, Île-de-France Region, 94010
About this study
All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.
- Conditions
- Neuropathic Pain Rebel
- Being tested
- implantation of stimulator
- Keywords
- Neuropathic pain, Electric cortical stimulation, Economic Medical evaluation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of stimulatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of treatment of this pathology
Secondary outcomes (1)
Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain RebelStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Jacques Lemaire, Principal investigator, Clermont-Ferrand UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241566
- Sponsor's protocol ID
- CHU63-0002
- Status last verified
- Jan 2010
- First submitted
- 17 Oct 2005
- Last updated
- 20 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
- ClinicalTrials.gov ID
- NCT00241566
- Acronym / sponsor ID
- CHU63-0002
- Conditions
- Neuropathic Pain Rebel
- Keywords
- Neuropathic pain, Electric cortical stimulation, Economic Medical evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Oct 2005 (estimated)
- 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.
All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of pain caused by lesion of central or peripheral nervous system
- Pain persistent since one year at least
- Pain untreated with 3 different antalgic treatments
Key exclusion criteria (2 listed)
- Pain linked t a malignant affection
- patient < 18 years-old
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 |
|---|---|---|
| implantation of stimulator | Device | – |
Primary outcome
Cost of treatment of this pathology
1 secondary outcome
Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.
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 20 Jan 2010.
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.
Jean-Jacques Lemaire principal investigator
Clermont-Ferrand UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing implantation of stimulator in people with Neuropathic Pain Rebel, run by University Hospital, Clermont-Ferrand at 2 sites 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 3 inclusion and 2 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 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cost of treatment of this pathology. 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 20 Jan 2010.