Efficacy of Non-Invasive Neuromodulation on Pain in Migraine
ENDIM
2 other identifiers
interventional
120
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
July 23, 2025
May 1, 2025
3 years
May 27, 2025
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variation of headaches days number per month
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%
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%.
between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment
Patient Global Impression of Change (PGIC)
at week 12
Other Outcomes (16)
Bang blinding index
week 0, week 2, week 4, week 6, week 8, week 12
Variation of blood cytokine levels
Before (Week 0) and after treatment (Weeks 8 and 12)
Variation of headaches days number per month
Every each 4-week period post-treatment, compared to 4 weeks before treatment initiation
- +13 more other outcomes
Study Arms (2)
rTMS stimulation
EXPERIMENTALsham rTMS stimulation
SHAM COMPARATORInterventions
robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
Eligibility Criteria
You may qualify if:
- 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;
- Information letter read and understood;
- Signed informed consent;
- Affiliation with a social security scheme.
You may not qualify if:
- 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
- Patients under guardianship or deprived of liberty.
- Pregnant or breast-feeding women
- Subject having already benefited from rTMS sessions in the past (to maintain the blind)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, France, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2025
First Posted
July 23, 2025
Study Start
July 31, 2025
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
July 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share