Clinical trial NCT00122915: CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Intractable
Facial Pain
Keywords: Motor Cortex Stimulation
Pain treatment
Central post-stroke pain (CPSP)
Trigeminal neuropathic pain (TGN)
Facial pain
Neurostimuation
Cortical lead
Neuropathic pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-07-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events reports
measure: Pain assessed by Visual Analogue Scale (VAS)
Secondary outcomes:
measure: Quality of life
measure: Disability
measure: Analgesic, sedative or psychoactive medication intake
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
city: Brussels
country: Belgium
facility: Hopital Erasme, Service de Neurochirurgie
city: Brussels
country: Belgium
facility: UCL St luc, Neurochirurgie
city: Gent
country: Belgium
facility: AZ St Lucas, Neurochirugie
city: Leuven
country: Belgium
facility: UZ Gasthuisberg , Department of Neurosurgery
city: Liège
country: Belgium
facility: CH de la Citadelle
city: Saint Niklaas
country: Belgium
facility: Maria Middelares ZH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Marburg
country: Germany
facility: Klinikum der Philipps-Universität Marburg
city: Barcelona
country: Spain
facility: Santa Creu I Sant Pau, Servicio de Neurocirugia
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon, Servicio de Neurologia
Study officials:
affiliation: UZ Gasthuisberg
name: Bart Nuttin, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: