CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain

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.

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