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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Intractable Facial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No