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

This study has been 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.)
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00122915
First received: July 21, 2005
Last updated: August 19, 2008
Last verified: August 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Medtronic:

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

Secondary Outcome Measures:
  • Quality of life
  • Disability
  • Analgesic, sedative or psychoactive medication intake

Estimated Enrollment: 104
Study Start Date: June 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122915

Locations
Austria
Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck, Austria, 6020
Belgium
UCL St luc, Neurochirurgie
Brussels, Belgium, 1200
Hopital Erasme, Service de Neurochirurgie
Brussels, Belgium, 1070
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
St. Niklaas, Belgium, 9100
Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35043
Spain
Santa Creu I Sant Pau, Servicio de Neurocirugia
Barcelona, Spain, 08025
Hospital Gregorio Maranon, Servicio de Neurologia
Madrid, Spain, 28007
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: Bart Nuttin, PhD, MD UZ Gasthuisberg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122915     History of Changes
Other Study ID Numbers: CONCEPT
Study First Received: July 21, 2005
Last Updated: August 19, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

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

ClinicalTrials.gov processed this record on October 20, 2014