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

NCT00122915 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-02-23

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Bart Nuttin, PhD, MD · UZ Gasthuisberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Austria
  • Belgium
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00122915 on ClinicalTrials.gov