Efficacy of Non-Invasive Neuromodulation on Pain in Migraine

NCT ID: NCT07081685

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-07-31

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.

Conditions

rTMS Stimulation; Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

rTMS stimulation

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex

sham rTMS stimulation

Group Type: SHAM_COMPARATOR

sham repetitive Magnetic Transcranial Stimulation (rTMS)

Intervention Type: DEVICE

sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS)

robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex

Intervention Type: DEVICE

sham repetitive Magnetic Transcranial Stimulation (rTMS)

sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, France, France

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

04.73.75.49.63

Facility Contacts

Lise LACLAUTRE

Role: primary

promo_interne_drci@chu-clermontferrand.fr

0473754963

Other Identifiers

2024-A01985-42

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC I 2023 MOISSET

Identifier Type: -

Identifier Source: org_study_id