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
About this trial
This is an interventional basic science trial for Headache focused on measuring TMS, CPM, headache, migraine, EEG, psychophysics
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
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
NCT ID
NCT01501045
First Posted
December 12, 2011
Last Updated
March 26, 2019
Sponsor
Rambam Health Care Campus
Collaborators
German Research Foundation
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
Learn more about this trial
Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)
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