Complex Regional Pain SyndromesNCT00217243
Evoked Fields After Median and Ulnar Stimulation
An observational study of Complex Regional Pain Syndromes, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Evoked fields before and after a local block (Xylocaine)
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2005to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: subjetcs were sampled from the hospital staff of two hospitals all patients were recruited from one hospital
Who may be able to join
- 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.
Who cannot join
- General condition
- Pregnancy
- Technical implants (pacemaker, SCS: disturbs MEG)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Center of Alkmaar
Alkmaar, North Holland, 1815 JD
About this study
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)
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.
Read the 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
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Evoked fields before and after a local block (Xylocaine)
- Keywords
- Pain, Magnetoencephalography, Median, Ulnar, Causalgia, Complex regional pain syndrome, Evoked fields, Nerve injury, Neuropathic pain
- Medical subject headings
- Complex Regional Pain Syndromes, Pain, Causalgia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoked fields before and after a local block (Xylocaine)Other
Also called 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
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
| Study group | Role | What they receive |
|---|---|---|
| Pain study Netherlands | 20 healthy subjects 20 patients with a traumatic unilateral peripheral nerve injury 20 patients with CRPS I Receives: Other: Evoked fields before and after a local block (Xylocaine) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Peter J Theuvenet, MD, Principal investigator, Medical Center Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217243
- Sponsor's protocol ID
- NH04-196
- Status last verified
- Sep 2009
- First submitted
- 19 Sep 2005
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10449261Theuvenet 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.
PubMed 16040256Theuvenet 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.
PubMed 16977490
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00217243
- Acronym / sponsor ID
- NH04-196
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Pain, Magnetoencephalography, Median, Ulnar, Causalgia, Complex regional pain syndrome, Evoked fields, Nerve injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- 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
- Study start
- Jun 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain study Netherlands | – | Other: Evoked fields before and after a local block (Xylocaine)20 healthy subjects 20 patients with a traumatic unilateral peripheral nerve injury 20 patients with CRPS I |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjetcs were sampled from the hospital staff of two hospitals all patients were recruited from one hospital
Key inclusion criteria (5 listed)
- (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).
- All the previous but evidence of traumatic peripheral nerve injury.
Key exclusion criteria (3 listed)
- General condition
- Pregnancy
- Technical implants (pacemaker, SCS: disturbs MEG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evoked fields before and after a local block (Xylocaine)Also: 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 20MEG 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 | Pain study Netherlands |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
- Background: PubMed 10449261Theuvenet 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.
- Results publication: PubMed 16040256Theuvenet 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.
- Results publication: PubMed 16977490Theuvenet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Theuvenet, MD principal investigator
Medical Center Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndromes, run by Medical Center Alkmaar at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00217243, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.