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Completed

NCT Number: NCT00217243

Evoked Fields After Median and Ulnar Stimulation

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.

Completed

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Key information

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center of Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Medical Center Alkmaar

Other

Collaborators

  • 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

Registry information

Official study 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)

Important dates

Study start
2005
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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