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)

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndromes
• Intervention / Treatment: Other: Evoked fields before and after a local block (Xylocaine)

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Netherlands
  • NH
    • Alkmaar, NH, Netherlands, 1815 JD
      • Medical Center of Alkmaar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjetcs were sampled from the hospital staff of two hospitals all patients were recruited from one hospital

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pain study Netherlands; 20 healthy subjects 20 patients with a traumatic unilateral peripheral nerve injury 20 patients with CRPS I

Other: Evoked 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; Other Names: All subjects were rated with the HC code, 1 to 20; All patients with nerve injury were rated with the A - code, 1 to 20; All patients with CRPS I were rated with the C - code, 1 to 20

Collaborators and Investigators

• Sponsor: Medical Center Alkmaar
• Collaborators: Aalborg University; VU University of Amsterdam; Technical University of Twente; Rudolf Magnus Institute - University of Utrecht; Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam; Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory - Motor Interaction,
• Investigators: Principal Investigator: Peter J Theuvenet, MD, Medical Center Alkmaar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Pain; Neuropathic pain; Magnetoencephalography; Causalgia; Nerve injury; Complex regional pain syndrome; Median; Ulnar; Evoked fields
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NH04-196