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Low field TMS as pain treatment as measured with quantitative sensory testing.


- candidate number2812
- NTR NumberNTR1093
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-okt-2007
- Secondary IDsmicroTMS001 UMCG
- Public TitleLow field TMS as pain treatment as measured with quantitative sensory testing.
- Scientific TitleLow field TMS as pain treatment as measured with quantitative sensory testing.
- ACRONYMmicroTMS-PAIN
- hypothesisLow field TMS can reduce nociceptive and neuropathic pain.
- Healt Condition(s) or Problem(s) studiedNeuropathic pain
- Inclusion criteria1. 18-80 years old;
2. subjectively healthy;
3. neuropathic pain (patients only).
- Exclusion criteria1. Neurological (e.g. epilepsy) history (volunteers only);
2. Neurological history apart from neuropathic pain (patients only);
3. Psychiatric history;
4. Recent use (within four weeks) of antidepressants, antiepileptic drugs or prescription psychopharmaca;
5. Excessive use of: coffee (>10 units per day), alcohol (>10 units per day);
6. Recent use (within four weeks) of cannabis or any other non-prescription psychopharmaca;
7. Presence in the body of MRI incompatible implants, electronic implants (e.g. cardiac pacemakers),or connectors of electronic equipment (e.g. electrodes).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-nov-2008
- Target number of participants100
- InterventionsTranscraniele magnetische stimulatie met zwakke velden.
- Primary outcomeSafety and tolerability in healthy volunteers and patients: any self-reported experiences are recorded. Small neuropsychological tests are performed such as long number recollection and reverse recital of the months of the year. Neuropathic pain model in healthy volunteers and neuropathic pain in patients: visual analogue scale of pain intensity.
Nociceptive pain model in healthy volunteers and patients: warmth detection threshold (oC) and heat pain threshold (oC).
- Secondary outcomeDuring the pain studies (as opposed to the safety and tolerability studies where this is the main endpoint) all subjects are debriefed about whether any sensations were perceived during the experiment.
- TimepointsTwo lab visits, approx. one week apart.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Kortekaas
- CONTACT for SCIENTIFIC QUERIES R. Kortekaas
- Sponsor/Initiator University of Groningen
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-okt-2007 - 20-mrt-2008


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