rTMS StimulationENDIMNCT07081685
Efficacy of Non-Invasive Neuromodulation on Pain in Migraine
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with rTMS Stimulation and Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective clinical study evaluating the analgesic efficacy of a non-medicated treatment: repeated transcranial magnetic stimulation (rTMS) of the primary motor cortex in chronic migraine (> 7 headache days per month and failure of at least 3 drug treatments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- rTMS Stimulation, Migraine
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years ;
- Frequent episodic or chronic migraine: migraine more than 8 days per month for more than 3 months;
- Maximum 26 headache days / 28 ;
- Failure (ineffectiveness, intolerance or contraindication) to at least 3 background drug treatments;
- Analgesic treatment stable for at least one month and will not need to be modified for the duration of the study;
- Patient can be followed throughout the study;
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- Information letter read and understood;
- Signed informed consent;
- Affiliation with a social security scheme.
Who cannot join
- Contraindication to rTMS (patient with conductive/sensitive material to magnetic fields implanted in the skull or less than 30 cm from the coil, implanted material controlled by physiological signals, history of epilepsy or unexplained seizures, drug treatment lowering the epileptic threshold, brain lesions in relation to the stimulation zone [of vascular, traumatic, tumoral, infectious or metabolic origin], sleep deprivation, alcoholism, treatment with electroconvulsive therapy in the previous month, uncontrolled intracranial hypertension,
- Contraindication to MRI (ferromagnetic material not compatible with MRI including: intracerebral metal clip, pacemaker, insulin pump, intrathecal pump, metal prosthesis; severe claustrophobia)§ drug or psychoactive substance abuse
- Presence of other pain more severe than that justifying inclusion
- Patients under guardianship or deprived of liberty.
- Pregnant or breast-feeding women
- Patients participating in another research protocol involving a drug in the 30 days prior to inclusion.
- Subject having already benefited from rTMS sessions in the past (to maintain the blind)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, France
Lise LACLAUTRE, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Xavier Moisset
About this study
This is a prospective clinical study evaluating the analgesic efficacy of a non-medicated treatment: repeated transcranial magnetic stimulation (rTMS) of the primary motor cortex in chronic migraine (> 7 headache days per month and failure of at least 3 drug treatments).
To this end, the study involves a double-blind, randomized, comparative experimental protocol against a sham control condition via 2 parallel groups comprising 60 patients each (N= 120 in total). Randomized block design with stratification by center and type of migraine (episodic or chronic).
Read more
5 rTMS sessions will be performed, with one stimulation session every 2 weeks. One group will receive active stimulation at each session (high-frequency stimulation of the left primary motor cortex, 2000 pulses per session, 80% of resting motor threshold) and the other group placebo stimulation (sham).
Depending on the randomization group, rTMS sessions will be carried out by trained experimenters in the investigating center where the patient has been included. The study is multicentric, with five centers, four of which are in the Auvergne-Rhône-Alpes region. Data will be centralized at the Clermont-Ferrand University Hospital, and statistical analysis will be carried out by the Clermont-Ferrand University Hospital's Clinical Research and Innovation Department. Principal difference analysis (active vs sham) performed in ITT; missing data processed by multiple imputation.
- Conditions
- rTMS Stimulation, Migraine
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS), sham repetitive Magnetic Transcranial Stimulation (rTMS)
- Keywords
- rTMS neurostimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (rTMS)Device
robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
sham repetitive Magnetic Transcranial Stimulation (rTMS)Device
sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
| Study group | Role | What they receive |
|---|---|---|
| rTMS stimulation | Experimental | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS) |
| sham rTMS stimulation | Sham comparator | Not described Receives: Device: sham repetitive Magnetic Transcranial Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of headaches days number per month
Measured: difference between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
Secondary outcomes (3)
variation in the number of headache (days per month) of at least 50%
Measured: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
variation in the number of headache (days per month) of at least 30%.
Measured: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
Patient Global Impression of Change (PGIC)
The score varies from 1 to 7 . A score of 1 means a better outcome and a score of 7 means a worse outcome
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for rTMS StimulationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081685
- Sponsor's protocol ID
- PHRC I 2023 MOISSET
- Other IDs
- 2024-A01985-42
- Acronym
- ENDIM
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-Invasive Neuromodulation on Pain in Migraine
- ClinicalTrials.gov ID
- NCT07081685
- Acronym / sponsor ID
- ENDIM / PHRC I 2023 MOISSET
- Conditions
- rTMS Stimulation, Migraine
- Keywords
- rTMS neurostimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- 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.
This is a prospective clinical study evaluating the analgesic efficacy of a non-medicated treatment: repeated transcranial magnetic stimulation (rTMS) of the primary motor cortex in chronic migraine (> 7 headache days per month and failure of at least 3 drug treatments).
To this end, the study involves a double-blind, randomized, comparative experimental protocol against a sham control condition via 2 parallel groups comprising 60 patients each (N= 120 in total). Randomized block design with stratification by center and type of migraine (episodic or chronic).
5 rTMS sessions will be performed, with one stimulation session every 2 weeks. One group will receive active stimulation at each session (high-frequency stimulation of the left primary motor cortex, 2000 pulses per session, 80% of resting motor threshold) and the other group placebo stimulation (sham).
Depending on the randomization group, rTMS sessions will be carried out by trained experimenters in the investigating center where the patient has been included. The study is multicentric, with five centers, four of which are in the Auvergne-Rhône-Alpes region. Data will be centralized at the Clermont-Ferrand University Hospital, and statistical analysis will be carried out by the Clermont-Ferrand University Hospital's Clinical Research and Innovation Department. Principal difference analysis (active vs sham) performed in ITT; missing data processed by multiple imputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS stimulation | Experimental | Device: repetitive Transcranial Magnetic Stimulation (rTMS) |
| sham rTMS stimulation | Sham comparator | Device: sham repetitive Magnetic Transcranial Stimulation (rTMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18 years ;
- Frequent episodic or chronic migraine: migraine more than 8 days per month for more than 3 months;
- Maximum 26 headache days / 28 ;
- Failure (ineffectiveness, intolerance or contraindication) to at least 3 background drug treatments;
- Analgesic treatment stable for at least one month and will not need to be modified for the duration of the study;
Key exclusion criteria (7 listed)
- Contraindication to rTMS (patient with conductive/sensitive material to magnetic fields implanted in the skull or less than 30 cm from the coil, implanted material controlled by physiological signals, history of epilepsy or unexplained seizures, drug treatment lowering the epileptic threshold, brain lesions in relation to the stimulation zone [of vascular, traumatic, tumoral, infectious or metabolic origin], sleep deprivation, alcoholism, treatment with electroconvulsive therapy in the previous month, uncontrolled intracranial hypertension,
- Contraindication to MRI (ferromagnetic material not compatible with MRI including: intracerebral metal clip, pacemaker, insulin pump, intrathecal pump, metal prosthesis; severe claustrophobia)§ drug or psychoactive substance abuse
- Presence of other pain more severe than that justifying inclusion
- Patients under guardianship or deprived of liberty.
- Pregnant or breast-feeding women
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 |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS)robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex | Device | rTMS stimulation |
| sham repetitive Magnetic Transcranial Stimulation (rTMS)sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex | Device | sham rTMS stimulation |
Primary outcome
Variation of headaches days number per month
Time frame: difference between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
3 secondary outcomes
variation in the number of headache (days per month) of at least 50%
Time frame: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
variation in the number of headache (days per month) of at least 30%.
Time frame: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
Patient Global Impression of Change (PGIC)
Time frame: at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with rTMS Stimulation and Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Jul 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04.73.75.49.63, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of headaches days number per month (time frame: difference between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment). 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 23 Jul 2025.