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Completed

NCT Number: NCT01501045

Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 18-70
  • males and females
  • right handed

Exclusion criteria

  • metal in brain/skull
  • cardiac pacemaker
  • cohlear implants
  • history of head trauma
  • history of epilepsy or seizures
  • pregnancy

Treatment and study plan

TMS system MagPro x100, Tonica Elektronik A/S, Denmark

Device

repeated TMS (rTMS)

Other names: Transcranial Magnetic Stimulator

Primary outcomes

  1. Pain scores as measured by pain numerical scale (NPS)

    Time frame: 1 week

    TMS directed to pain inhibitory cortical areas will evoke pain reduction

  2. Amplitude of pain-evoked potentials

    Time frame: 1 week

    Change in pain evoked potentials will be assessed before and after the TMS

Secondary outcomes

  1. conditioned pain modulation (CPM)

    Time frame: 1 week

    Change in the efficiency of CPM will be assessed in response to TMS

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

The Effect of Transmagnetic Stimulation on Descending Pain Modulation

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2011
Registry last updated
Mar 27, 2019

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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