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

Phase 3

Terminated

• Conditions: Facial Pain; Pain, Intractable

• Registration Number: NCT00122915
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Adverse events reports
Pain assessed by Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Quality of life
Analgesic, sedative or psychoactive medication intake
Disability

Trial Locations

Locations (11)

Klinikum der Philipps-Universität Marburg; 🇩🇪 Marburg, Germany

AZ St Lucas, Neurochirugie; 🇧🇪 Gent, Belgium

Santa Creu I Sant Pau, Servicio de Neurocirugia; 🇪🇸 Barcelona, Spain

Universitätsklinikum Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Germany

Hospital Gregorio Maranon, Servicio de Neurologia; 🇪🇸 Madrid, Spain

Hopital Erasme, Service de Neurochirurgie; 🇧🇪 Brussels, Belgium

UCL St luc, Neurochirurgie; 🇧🇪 Brussels, Belgium

Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie; 🇦🇹 Innsbruck, Austria

CH de la Citadelle; 🇧🇪 Liège, Belgium

Maria Middelares ZH; 🇧🇪 Saint Niklaas, Belgium

UZ Gasthuisberg , Department of Neurosurgery; 🇧🇪 Leuven, Belgium