Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

The Effect of Transmagnetic Stimulation on Descending Pain Modulation

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Headache
• Intervention / Treatment: Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark; Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: healthy subjects	Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark; repeated TMS (rTMS); Other Names: Transcranial Magnetic Stimulator; Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark; repeated TMS; Other Names: Transcranial Magnetic Stimulator
EXPERIMENTAL: pain patients; Migraine and muscle headache patients	Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark; repeated TMS (rTMS); Other Names: Transcranial Magnetic Stimulator; Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark; repeated TMS; Other Names: Transcranial Magnetic Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores as measured by pain numerical scale (NPS)	TMS directed to pain inhibitory cortical areas will evoke pain reduction	1 week
Amplitude of pain-evoked potentials	Change in pain evoked potentials will be assessed before and after the TMS	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conditioned pain modulation (CPM)	Change in the efficiency of CPM will be assessed in response to TMS	1 week

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: German Research Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): November 6, 2017
• Study Completion (ACTUAL): November 6, 2017

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (ESTIMATE): December 29, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: EEG; headache; migraine; TMS; CPM; psychophysics
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: TMS-001