NCT01501045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

6.9 years

First QC Date

December 12, 2011

Last Update Submit

March 26, 2019

Conditions

Keywords

TMSCPMheadachemigraineEEGpsychophysics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • conditioned pain modulation (CPM)

    1 week

Study Arms (2)

healthy subjects

EXPERIMENTAL

healthy subjects

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

pain patients

EXPERIMENTAL

Migraine and muscle headache patients

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

Interventions

repeated TMS (rTMS)

Also known as: Transcranial Magnetic Stimulator
healthy subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Haifa, Israel

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David Yarnitsky, professor

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of Neurology Department

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 29, 2011

Study Start

January 1, 2011

Primary Completion

November 6, 2017

Study Completion

November 6, 2017

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations