Text Size

Evoked Fields After Median and Ulnar Stimulation

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00217243
First received: September 19, 2005
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Complex Regional Pain Syndromes
 Other: Evoked fields before and after a local block (Xylocaine)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Center Alkmaar:

Enrollment: 60
Study Start Date: June 2005
Study Completion Date: June 2007
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217243

Locations
Netherlands
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
Investigators
Principal Investigator: Peter J Theuvenet, MD Medical Center Alkmaar
  More Information

Publications:

Responsible Party: P.J. Theuvenet, anesthesiologist, Medical Center Alkmaar, The Netherlands
ClinicalTrials.gov Identifier: NCT00217243     History of Changes
Other Study ID Numbers: NH04-196
Study First Received: September 19, 2005
Last Updated: September 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medical Center Alkmaar:
Pain
Magnetoencephalography
Median
Ulnar
Causalgia
 Complex regional pain syndrome
Evoked fields
Nerve injury
Neuropathic pain

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013