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

NCT00122915 | Terminated Phase 3

• 1 other identifier: CONCEPT
• Study Type: interventional
• Target: 104
• Locations: 4 countries
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (2)

• Adverse events reports

• Pain assessed by Visual Analogue Scale (VAS)

Secondary Outcomes (3)

• Quality of life

• Disability

• Analgesic, sedative or psychoactive medication intake

Interventions

Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (11)

Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie

Innsbruck, 6020, Austria

Location

Hopital Erasme, Service de Neurochirurgie

Brussels, 1070, Belgium

Location

UCL St luc, Neurochirurgie

Brussels, 1200, Belgium

Location

AZ St Lucas, Neurochirugie

Ghent, 9000, Belgium

Location

UZ Gasthuisberg , Department of Neurosurgery

Leuven, 3000, Belgium

Location

CH de la Citadelle

Liège, 4000, Belgium

Location

Maria Middelares ZH

Saint Niklaas, 9100, Belgium

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Klinikum der Philipps-Universität Marburg

Marburg, 35043, Germany

Location

Santa Creu I Sant Pau, Servicio de Neurocirugia

Barcelona, 08025, Spain

Location

Hospital Gregorio Maranon, Servicio de Neurologia

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Pain, Intractable; Facial Pain; Agnosia; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Bart Nuttin, PhD, MD

  UZ Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: June 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

DE (2); ES (2); BE (6); AU (1)