Evoked Fields After Median and Ulnar Stimulation

Sponsor

Medical Center Alkmaar (Other)

Overall Status

Completed

CT.gov ID

NCT00217243

Collaborator

Rudolf Magnus Institute - University of Utrecht (Other), Technical University of Twente (Other), VU University of Amsterdam (Other), Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam (Other), Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory - Motor Interaction, (Other), Aalborg University (Other)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndromes	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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center of Alkmaar	Alkmaar	NH	Netherlands	1815 JD

Sponsors and Collaborators

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