NCT00217243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

First QC Date

September 19, 2005

Last Update Submit

September 17, 2009

Conditions

Complex Regional Pain Syndromes

Keywords

PainMagnetoencephalographyMedianUlnarCausalgiaComplex regional pain syndromeEvoked fieldsNerve injuryNeuropathic pain

Study Arms (1)

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)

Interventions

Evoked fields before and after a local block (Xylocaine)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

Also known as: 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
Pain study Netherlands

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • General condition
  • Pregnancy
  • Technical implants (pacemaker, SCS: disturbs MEG)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

Location

Related 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. doi: 10.1023/a:1022210704505.

    PMID: 10449261BACKGROUND

  • 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.

    PMID: 16040256RESULT

  • 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.

    PMID: 16977490RESULT

MeSH Terms

Conditions

Complex Regional Pain SyndromesPainCausalgiaNeuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Peter J Theuvenet, MD

    Medical Center Alkmaar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2007

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

NL(1)