Back to resultsCONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
Primary Purpose
Pain, Intractable, Facial Pain
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Intractable focused on measuring Motor Cortex Stimulation, Pain treatment, Central post-stroke pain (CPSP), Trigeminal neuropathic pain (TGN), Facial pain, Neurostimuation, Cortical lead, Neuropathic 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
Sites / Locations
- Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
- Hopital Erasme, Service de Neurochirurgie
- UCL St luc, Neurochirurgie
- AZ St Lucas, Neurochirugie
- UZ Gasthuisberg , Department of Neurosurgery
- CH de la Citadelle
- Maria Middelares ZH
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
- Klinikum der Philipps-Universität Marburg
- Santa Creu I Sant Pau, Servicio de Neurocirugia
- Hospital Gregorio Maranon, Servicio de Neurologia
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00122915
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator
Primary Outcome Measure Information:
Title
Adverse events reports
Title
Pain assessed by Visual Analogue Scale (VAS)
Secondary Outcome Measure Information:
Title
Quality of life
Title
Disability
Title
Analgesic, sedative or psychoactive medication intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Nuttin, PhD, MD
Organizational Affiliation
UZ Gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hopital Erasme, Service de Neurochirurgie
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL St luc, Neurochirurgie
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ St Lucas, Neurochirugie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gasthuisberg , Department of Neurosurgery
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CH de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Maria Middelares ZH
City
Saint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Santa Creu I Sant Pau, Servicio de Neurocirugia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Gregorio Maranon, Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
We'll reach out to this number within 24 hrs