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

Medtronic

Status and phase

Terminated

Phase 3

Conditions

Pain, Intractable

Facial Pain

Treatments

Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00122915

CONCEPT

Details and patient eligibility

About

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.

Enrollment

104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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