Clinical trial NCT00217243: Evoked Fields After Median and Ulnar Stimulation
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Regional Pain Syndromes
Keywords: Pain
Magnetoencephalography
Median
Ulnar
Causalgia
Complex regional pain syndrome
Evoked fields
Nerve injury
Neuropathic pain
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
Collaborators: name: Rudolf Magnus Institute - University of Utrecht
name: Technical University of Twente
name: VU University of Amsterdam
name: Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam
name: Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory - Motor Interaction,
name: Aalborg University
First posted: 2005-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjetcs were sampled from the hospital staff of two hospitals all patients were recruited from one hospital

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

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center of Alkmaar
state: NH
Study officials:
affiliation: Medical Center Alkmaar
name: Peter J Theuvenet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theuvenet PJ, Dunajski Z, Peters MJ, van Ree JM. Responses to median and tibial nerve stimulation in patients with chronic neuropathic pain. Brain Topogr. 1999 Summer;11(4):305-13. doi: 10.1023/a:1022210704505.
citation: Theuvenet PJ, van Dijk BW, Peters MJ, van Ree JM, Lopes da Silva FL, Chen AC. Whole-head MEG analysis of cortical spatial organization from unilateral stimulation of median nerve in both hands: no complete hemispheric homology. Neuroimage. 2005 Nov 1;28(2):314-25. doi: 10.1016/j.neuroimage.2005.06.010. Epub 2005 Jul 22.
citation: Theuvenet PJ, van Dijk BW, Peters MJ, van Ree JM, Lopes da Silva FL, Chen AC. Cortical characterization and inter-dipole distance between unilateral median versus ulnar nerve stimulation of both hands in MEG. Brain Topogr. 2006 Winter;19(1-2):29-42. doi: 10.1007/s10548-006-0010-1.