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Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TMS system MagPro x100, Tonica Elektronik A/S, Denmark
TMS system MagPro x100, Tonica Elektronik A/S, Denmark
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Headache focused on measuring TMS, CPM, headache, migraine, EEG, psychophysics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

healthy subjects

pain patients

Arm Description

healthy subjects

Migraine and muscle headache patients

Outcomes

Primary Outcome Measures

Pain scores as measured by pain numerical scale (NPS)
TMS directed to pain inhibitory cortical areas will evoke pain reduction
Amplitude of pain-evoked potentials
Change in pain evoked potentials will be assessed before and after the TMS

Secondary Outcome Measures

conditioned pain modulation (CPM)
Change in the efficiency of CPM will be assessed in response to TMS

Full Information

First Posted
December 12, 2011
Last Updated
March 26, 2019
Sponsor
Rambam Health Care Campus
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01501045
Brief Title
Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)
Official Title
The Effect of Transmagnetic Stimulation on Descending Pain Modulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
TMS, CPM, headache, migraine, EEG, psychophysics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy subjects
Arm Type
Experimental
Arm Description
healthy subjects
Arm Title
pain patients
Arm Type
Experimental
Arm Description
Migraine and muscle headache patients
Intervention Type
Device
Intervention Name(s)
TMS system MagPro x100, Tonica Elektronik A/S, Denmark
Other Intervention Name(s)
Transcranial Magnetic Stimulator
Intervention Description
repeated TMS (rTMS)
Intervention Type
Device
Intervention Name(s)
TMS system MagPro x100, Tonica Elektronik A/S, Denmark
Other Intervention Name(s)
Transcranial Magnetic Stimulator
Intervention Description
repeated TMS
Primary Outcome Measure Information:
Title
Pain scores as measured by pain numerical scale (NPS)
Description
TMS directed to pain inhibitory cortical areas will evoke pain reduction
Time Frame
1 week
Title
Amplitude of pain-evoked potentials
Description
Change in pain evoked potentials will be assessed before and after the TMS
Time Frame
1 week
Secondary Outcome Measure Information:
Title
conditioned pain modulation (CPM)
Description
Change in the efficiency of CPM will be assessed in response to TMS
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yarnitsky, professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

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