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Evoked Fields After Median and Ulnar Stimulation

Evoked (Magnetic) Cortical Fields for the Comparative Study of Mechanisms Underlying Chronic Non-malignant Pain in Peripheral Nerve Injury (CRPS II) and CRPS I (Chronic Regional Pain Syndrome I)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00217243
Enrollment
60
Registered
2005-09-22
Start date
2005-06-30
Completion date
2007-06-30
Last updated
2009-09-18

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

Conditions

Complex Regional Pain Syndromes

Keywords

Pain, Magnetoencephalography, Median, Ulnar, Causalgia, Complex regional pain syndrome, Evoked fields, Nerve injury, Neuropathic pain

Brief summary

In order to be able to study the effects of evoked fields with magnetoencephalography (MEG) in two groups of patients, comparison is made with a group of healthy volunteers.

Detailed description

This study is directed at the (central and / or peripheral) mechanisms of pain and the cortical changes (plasticity) due to chronic non-malignant pain in two groups of patients and one healthy volunteer group. The aim of the study is further to evaluate cortical processes by MEG (and fMRI, if feasible) to quantify and qualify the responses, localise the generators and study the effects of a pain therapy. To search for patterns that may result in diagnostic criteria and have an indicative value for the treatment and the monitoring of the effects. Finally the study not only intends to support clinical diagnosis but also to provide tools to monitor treatment and support the choice (algorithm) between SCS and SAN. An algorithm, facilitating decision making between these two treatments, will be promoted. It should also provide a clinical decision tool for the use of SAN

Interventions

OTHEREvoked fields before and after a local block (Xylocaine)

MEG registration after electrical median and ulnar nerve stimulation in subjects and patients. In the patient group another MEG was performed after an anaesthetic block (1-2 ml Lidocaine 1%) at the site of the nerve injury producing a painfree state

Sponsors

Rudolf Magnus Institute - University of Utrecht
CollaboratorOTHER
Technical University of Twente
CollaboratorOTHER
VU University of Amsterdam
CollaboratorOTHER
Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam
CollaboratorOTHER
Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory - Motor Interaction,
CollaboratorUNKNOWN
Aalborg University
CollaboratorOTHER
Medical Center Alkmaar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

CRPS I: * (Absolute) functio laesa, secondary pain and cold sensations * (Relative) abnormal skin colour, allodynia, hyperalgesia, hyperpathia, hyperhydrosis,oedema, increased nail growth, increased hair growth. (At least 4 need to be present). CRPS II: * All the previous but evidence of traumatic peripheral nerve injury.

Exclusion criteria

* General condition * Pregnancy * Technical implants (pacemaker, SCS: disturbs MEG)

Countries

Netherlands

Outcome results

None listed

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