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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122915
Recruitment Status : Terminated (Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns.)
First Posted : July 22, 2005
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pain, Intractable Facial Pain Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Primary Outcome Measures :
  1. Adverse events reports
  2. Pain assessed by Visual Analogue Scale (VAS)

Secondary Outcome Measures :
  1. Quality of life
  2. Disability
  3. Analgesic, sedative or psychoactive medication intake

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122915

Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck, Austria, 6020
Hopital Erasme, Service de Neurochirurgie
Brussels, Belgium, 1070
UCL St luc, Neurochirurgie
Brussels, Belgium, 1200
AZ St Lucas, Neurochirugie
Gent, Belgium, 9000
UZ Gasthuisberg , Department of Neurosurgery
Leuven, Belgium, 3000
CH de la Citadelle
Liège, Belgium, 4000
Maria Middelares ZH
Saint Niklaas, Belgium, 9100
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35043
Santa Creu I Sant Pau, Servicio de Neurocirugia
Barcelona, Spain, 08025
Hospital Gregorio Maranon, Servicio de Neurologia
Madrid, Spain, 28007
Sponsors and Collaborators
Principal Investigator: Bart Nuttin, PhD, MD UZ Gasthuisberg

Responsible Party: MedtronicNeuro Identifier: NCT00122915     History of Changes
Other Study ID Numbers: CONCEPT
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by MedtronicNeuro:
Motor Cortex Stimulation
Pain treatment
Central post-stroke pain (CPSP)
Trigeminal neuropathic pain (TGN)
Facial pain
Cortical lead
Neuropathic pain

Additional relevant MeSH terms:
Facial Pain
Pain, Intractable
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms