CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
This study has been terminated.
(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.)
Sponsor:
Medtronic
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00122915
First received: July 21, 2005
Last updated: August 19, 2008
Last verified: August 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain, Intractable Facial Pain |
Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Further study details as provided by Medtronic:
Primary Outcome Measures:
- Adverse events reports
- Pain assessed by Visual Analogue Scale (VAS)
Secondary Outcome Measures:
- Quality of life
- Disability
- Analgesic, sedative or psychoactive medication intake
| Estimated Enrollment: | 104 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122915
Locations
| Austria | |
| Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| Hopital Erasme, Service de Neurochirurgie | |
| Brussels, Belgium, 1070 | |
| UCL St luc, Neurochirurgie | |
| Brussels, Belgium, 1200 | |
| AZ St Lucas, Neurochirugie | |
| Gent, Belgium, 9000 | |
| UZ Gasthuisberg , Department of Neurosurgery | |
| Leuven, Belgium, 3000 | |
| CH de la Citadelle | |
| Liège, Belgium, 4000 | |
| Maria Middelares ZH | |
| St. Niklaas, Belgium, 9100 | |
| Germany | |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | |
| Lübeck, Germany, 23538 | |
| Klinikum der Philipps-Universität Marburg | |
| Marburg, Germany, 35043 | |
| Spain | |
| Santa Creu I Sant Pau, Servicio de Neurocirugia | |
| Barcelona, Spain, 08025 | |
| Hospital Gregorio Maranon, Servicio de Neurologia | |
| Madrid, Spain, 28007 | |
Sponsors and Collaborators
Medtronic
Investigators
| Principal Investigator: | Bart Nuttin, PhD, MD | UZ Gasthuisberg |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00122915 History of Changes |
| Other Study ID Numbers: | CONCEPT |
| Study First Received: | July 21, 2005 |
| Last Updated: | August 19, 2008 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Keywords provided by Medtronic:
|
Motor Cortex Stimulation Pain treatment Central post-stroke pain (CPSP) Trigeminal neuropathic pain (TGN) |
Facial pain Neurostimuation Cortical lead Neuropathic pain |
Additional relevant MeSH terms:
|
Facial Pain Neuralgia Pain, Intractable Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Peripheral Nervous System Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013