CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
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ClinicalTrials.gov Identifier: NCT00122915
(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.)
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 or disease
Pain, IntractableFacial Pain
Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator
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
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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