Evoked Fields After Median and Ulnar Stimulation

NCT ID: NCT00217243

Last Updated: 2009-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-06-30

Brief Summary

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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

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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

Conditions

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Complex Regional Pain Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pain study Netherlands

20 healthy subjects 20 patients with a traumatic unilateral peripheral nerve injury 20 patients with CRPS I

Evoked fields before and after a local block (Xylocaine)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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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)
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rudolf Magnus Institute - University of Utrecht

OTHER

Sponsor Role collaborator

Technical University of Twente

OTHER

Sponsor Role collaborator

VU University of Amsterdam

OTHER

Sponsor Role collaborator

Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam

OTHER

Sponsor Role collaborator

Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory - Motor Interaction,

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Medical Center Alkmaar

OTHER

Sponsor Role lead

Responsible Party

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Medical Center Alkmaar, The Netherlands

Principal Investigators

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Peter J Theuvenet, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Locations

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Medical Center of Alkmaar

Alkmaar, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 10449261 (View on PubMed)

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.

Reference Type RESULT
PMID: 16040256 (View on PubMed)

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.

Reference Type RESULT
PMID: 16977490 (View on PubMed)

Other Identifiers

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NH04-196

Identifier Type: -

Identifier Source: org_study_id

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