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

MedtronicNeuro11 sites in 4 countries104 target enrollmentJune 2005

ConditionsPain, Intractable Facial Pain

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pain, Intractable
Sponsor: MedtronicNeuro
Enrollment: 104
Locations: 11
Primary Endpoint: Adverse events reports
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

March 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

Eligibility 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