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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122915

Enrollment

104

Registered

2005-07-22

Start date

2005-06-30

Completion date

2008-03-31

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Pain, Pain, Intractable

Keywords

Motor Cortex Stimulation, Pain treatment, Central post-stroke pain (CPSP), Trigeminal neuropathic pain (TGN), Facial pain, Neurostimuation, Cortical lead, Neuropathic pain

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events reports	—
Pain assessed by Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Quality of life	—
Disability	—
Analgesic, sedative or psychoactive medication intake	—

Countries

Austria, Belgium, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026