HeadacheNCT01501045
Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)
A study testing TMS system MagPro x100, Tonica Elektronik A/S, Denmark in people with Headache and Migraine, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- TMS system MagPro x100, Tonica Elektronik A/S, Denmark
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to 6 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-70
- males and females
- right handed
Who cannot join
- metal in brain/skull
- cardiac pacemaker
- cohlear implants
- history of head trauma
- history of epilepsy or seizures
- pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center
Haifa
About this study
Official title: 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.
Read the 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.
- Being tested
- TMS system MagPro x100, Tonica Elektronik A/S, Denmark
- Keywords
- TMS, CPM, headache, migraine, EEG, psychophysics
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS system MagPro x100, Tonica Elektronik A/S, DenmarkDevice
Also called Transcranial Magnetic Stimulator
repeated TMS (rTMS)
TMS system MagPro x100, Tonica Elektronik A/S, DenmarkDevice
Also called Transcranial Magnetic Stimulator
repeated TMS
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | healthy subjects Receives: Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark |
| pain patients | Experimental | Migraine and muscle headache patients Receives: Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores as measured by pain numerical scale (NPS)
TMS directed to pain inhibitory cortical areas will evoke pain reduction
Measured: 1 week
Amplitude of pain-evoked potentials
Change in pain evoked potentials will be assessed before and after the TMS
Measured: 1 week
Secondary outcomes (1)
conditioned pain modulation (CPM)
Change in the efficiency of CPM will be assessed in response to TMS
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2011
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, d_yarnitsky, Rambam Health Care Campus
- Investigators
- David Yarnitsky, professor, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501045
- Sponsor's protocol ID
- TMS-001
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2011
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transmagnetic Stimulation on Descending Pain Modulation
- ClinicalTrials.gov ID
- NCT01501045
- Acronym / sponsor ID
- TMS-001
- Keywords
- TMS, CPM, headache, migraine, EEG, psychophysics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2011 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Device: TMS system MagPro x100, Tonica Elektronik A/S, Denmarkhealthy subjects |
| pain patients | Experimental | Device: TMS system MagPro x100, Tonica Elektronik A/S, DenmarkMigraine and muscle headache patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-70
- males and females
- right handed
Key exclusion criteria (6 listed)
- metal in brain/skull
- cardiac pacemaker
- cohlear implants
- history of head trauma
- history of epilepsy or seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS system MagPro x100, Tonica Elektronik A/S, DenmarkAlso: Transcranial Magnetic Stimulatorrepeated TMS (rTMS) | Device | healthy subjects |
| TMS system MagPro x100, Tonica Elektronik A/S, DenmarkAlso: Transcranial Magnetic Stimulatorrepeated TMS | Device | pain patients |
Primary outcome
Pain scores as measured by pain numerical scale (NPS)
Time frame: 1 week
TMS directed to pain inhibitory cortical areas will evoke pain reduction
Amplitude of pain-evoked potentials
Time frame: 1 week
Change in pain evoked potentials will be assessed before and after the TMS
1 secondary outcome
conditioned pain modulation (CPM)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Yarnitsky, professor principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS system MagPro x100, Tonica Elektronik A/S, Denmark in people with Headache and Migraine, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores as measured by pain numerical scale (NPS) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.