An interventional study of TMS system MagPro x100, Tonica Elektronik A/S, Denmark and TMS system MagPro x100, Tonica Elektronik A/S, Denmark in Headache and Migraine, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Basic science
While some indications of the neural circuits involved in the Conditioned Pain Modulation (CPM) process are now available, there is still need to clarify what parts of the brain are essential for this process, whether the spino-brainstem loop is largely sufficient to explain CPM or whether other cerebral and spinal regions such as frontal, somatosensory and other cortical regions contribute substantially. Whereas mere observation of correlation between these circuits while activated by brain imaging is still of considerable interest, direct experimental manipulations by repetitive transcranial magnetic stimulation (rTMS) could even establish insights into causal relationships.
rTMS of different intensities, frequencies and location will be applied during CPM to evaluate the central mechanisms of pain modulation, their location and role in pain reduction through enhancement or suppression of activity in the relevant brain regions. In other words, cortical regions that may be implicated in CPM will be determined by augmenting or interrupting their activity via rTMSapplied to the areas under investigation. The regions will be the pain network sites, which are assumed to control the top-down influence on CPM and are superficial enough to be stimulated by the magnetic coil. These include primarily DLPFC (dorsolateral prefrontal cortex) and OFC (orbitofrontal cortex), with possible later addition of other relevant sites such as ACC (anterior cortex cinguli), insula and somatosensory cortices, etc. Since rTMS may be administered in a manner that either reduces or enhances the excitability of the stimulated cortical region, it should be possible to clarify the inhibitory or excitatory role of these regions in the CPM process. In summary, the planned studies should allow for identifying the cortical regions of the descending pain system, which are critical as starting points for the top-down modulation of CPM.
1,235 studies on the registry are indexed under Headache; 201 are open to participants now.
This study's enrollment of 94 is above the median of 60 across 926 interventional studies indexed under Headache.
Browse Headache studies →Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
healthy subjects
Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark
Migraine and muscle headache patients
Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark
repeated TMS (rTMS)
Also known as: Transcranial Magnetic Stimulator
repeated TMS
Also known as: Transcranial Magnetic Stimulator
Pain scores as measured by pain numerical scale (NPS)
TMS directed to pain inhibitory cortical areas will evoke pain reduction
Time frame: 1 week
Amplitude of pain-evoked potentials
Change in pain evoked potentials will be assessed before and after the TMS
Time frame: 1 week
conditioned pain modulation (CPM)
Change in the efficiency of CPM will be assessed in response to TMS
Time frame: 1 week
Ran from Jan 2011 to primary completion in Nov 2017, 82 months.
Of 314 non-industry interventional studies with no phase under Headache, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 82 months is above that.
Counting every sponsor, half of 335 studies reached it within 12 months; a quarter within 5 and three quarters within 32.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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