Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01501045
First received: December 12, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Headache
Migraine
Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of Transmagnetic Stimulation on Descending Pain Modulation

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Pain scores as measured by pain numerical scale (NPS) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    TMS directed to pain inhibitory cortical areas will evoke pain reduction

  • Amplitude of pain-evoked potentials [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Change in pain evoked potentials will be assessed before and after the TMS


Secondary Outcome Measures:
  • conditioned pain modulation (CPM) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Change in the efficiency of CPM will be assessed in response to TMS


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy subjects
healthy subjects
Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark
repeated TMS (rTMS)
Other Name: Transcranial Magnetic Stimulator
Experimental: pain patients
Migraine and muscle headache patients
Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark
repeated TMS
Other Name: Transcranial Magnetic Stimulator

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501045

Contacts
Contact: Yelena Granovsky, PhD 502075750 ext +972 y_granovsky@rambam.health.gov.il

Locations
Israel
The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Yelena Granovsky, PhD    +972 502065750      
Principal Investigator: David Yarnitsky, MD         
Sponsors and Collaborators
Rambam Health Care Campus
German Research Foundation
Investigators
Principal Investigator: David Yarnitsky, professor Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: d_yarnitsky, head of Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01501045     History of Changes
Other Study ID Numbers: TMS-001
Study First Received: December 12, 2011
Last Updated: December 28, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
TMS
CPM
headache
migraine
EEG
psychophysics

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014