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

Pain, Intractable Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122915
• Other study ID #: CONCEPT
• Status: Terminated
• Phase: Phase 3
• First received: July 21, 2005
• Last updated: February 21, 2018
• Start date: June 2005
• Est. completion date: March 2008

Study information

• Verified date: February 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Neuralgia
• Pain, Intractable

Intervention

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

Locations

Country	Name	City	State
Austria	Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie	Innsbruck
Belgium	Hopital Erasme, Service de Neurochirurgie	Brussels
Belgium	UCL St luc, Neurochirurgie	Brussels
Belgium	AZ St Lucas, Neurochirugie	Gent
Belgium	UZ Gasthuisberg , Department of Neurosurgery	Leuven
Belgium	CH de la Citadelle	Liège
Belgium	Maria Middelares ZH	Saint Niklaas
Germany	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck
Germany	Klinikum der Philipps-Universität Marburg	Marburg
Spain	Santa Creu I Sant Pau, Servicio de Neurocirugia	Barcelona
Spain	Hospital Gregorio Maranon, Servicio de Neurologia	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events reports
Primary	Pain assessed by Visual Analogue Scale (VAS)
Secondary	Quality of life
Secondary	Disability
Secondary	Analgesic, sedative or psychoactive medication intake