Evoked Fields After Median and Ulnar Stimulation

Complex Regional Pain Syndromes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217243
• Other study ID #: NH04-196
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: September 17, 2009
• Start date: June 2005
• Est. completion date: June 2007

Study information

• Verified date: September 2009
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders

Intervention

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

Locations

Country	Name	City	State
Netherlands	Medical Center of Alkmaar	Alkmaar	NH

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. — View 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 — View Citation