Pain, IntractablePhase 3NCT00122915
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
A Phase 3 study testing Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator in people with Pain, Intractable and Facial Pain, run by MedtronicNeuro at 11 sites in 4 countries.
Trial summary
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Facial Pain
- What is being tested?
- Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Jun 2005to Mar 2008
- Phase
- Phase 3
- 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
- CPSP or TGN/facial pain refractory to other medical treatments
- Pain > 1 year prior to baseline
- Pain intensity with an average daily VAS score > 5 demonstrated by 12 ratings across 4 days
- Stable pain medication for > 1 month prior to baseline
Who cannot join
- CPSP with important paresis/severe motor deficit in the area of pain
- TGN/facial pain with complete deafferentation pain
- Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified
- Pain associated with malignant neoplastic disease anywhere in the body or head
- History of epilepsy
- Presence of a deterioration of cognitive functions
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Belgium6 sites
Hopital Erasme, Service de Neurochirurgie
Brussels, 1070
UCL St luc, Neurochirurgie
Brussels, 1200
AZ St Lucas, Neurochirugie
Ghent, 9000
UZ Gasthuisberg , Department of Neurosurgery
Leuven, 3000
CH de la Citadelle
Liège, 4000
Maria Middelares ZH
Saint Niklaas, 9100
Germany2 sites
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Klinikum der Philipps-Universität Marburg
Marburg, 35043
Spain2 sites
Santa Creu I Sant Pau, Servicio de Neurocirugia
Barcelona, 08025
Hospital Gregorio Maranon, Servicio de Neurologia
Madrid, 28007
Austria1 site
Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck, 6020
About this study
Official title: A Prospective, Randomized, Double Blind, Crossover, Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.
- Conditions
- Pain, Intractable, Facial Pain
- Being tested
- Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator
- Keywords
- Motor Cortex Stimulation, Pain treatment, Central post-stroke pain (CPSP), Trigeminal neuropathic pain (TGN), Facial pain, Neurostimuation, Cortical lead, Neuropathic pain
- Medical subject headings
- Pain, Intractable, Facial Pain, Agnosia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events reports
Pain assessed by Visual Analogue Scale (VAS)
Secondary outcomes (3)
Quality of life
Disability
Analgesic, sedative or psychoactive medication intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Nuttin, PhD, MD, Principal investigator, UZ Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122915
- Sponsor's protocol ID
- CONCEPT
- Status last verified
- Feb 2018
- First submitted
- 21 Jul 2005
- Last updated
- 23 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Crossover, Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00122915
- Acronym / sponsor ID
- CONCEPT
- Conditions
- Pain, Intractable, Facial Pain
- Keywords
- Motor Cortex Stimulation, Pain treatment, Central post-stroke pain (CPSP), Trigeminal neuropathic pain (TGN), Facial pain, Neurostimuation, Cortical lead, Neuropathic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns.
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Jul 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.
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.
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 (4 listed)
- CPSP or TGN/facial pain refractory to other medical treatments
- Pain > 1 year prior to baseline
- Pain intensity with an average daily VAS score > 5 demonstrated by 12 ratings across 4 days
- Stable pain medication for > 1 month prior to baseline
Key exclusion criteria (6 listed)
- CPSP with important paresis/severe motor deficit in the area of pain
- TGN/facial pain with complete deafferentation pain
- Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified
- Pain associated with malignant neoplastic disease anywhere in the body or head
- History of epilepsy
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 |
|---|---|---|
| Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator | Device | – |
Primary outcome
Adverse events reports
Pain assessed by Visual Analogue Scale (VAS)
3 secondary outcomes
Quality of life
Disability
Analgesic, sedative or psychoactive medication intake
Results and safety
The study was stopped early (reason given: Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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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.
Bart Nuttin, PhD, MD principal investigator
UZ Gasthuisberg
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator in people with Pain, Intractable and Facial Pain, run by MedtronicNeuro at 11 sites in 4 countries.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Germany, Spain, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns.). Results are not available in the source record.
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?
Adverse events reports. The study lists 2 primary outcomes in all. 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 Feb 2018.