Status:
TERMINATED
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
Lead Sponsor:
MedtronicNeuro
Conditions:
Pain, Intractable
Facial Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00122915
Start Date
June 1 2005
End Date
March 1 2008
Last Update
February 23 2018
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck, Austria, 6020
2
Hopital Erasme, Service de Neurochirurgie
Brussels, Belgium, 1070
3
UCL St luc, Neurochirurgie
Brussels, Belgium, 1200
4
AZ St Lucas, Neurochirugie
Ghent, Belgium, 9000