Efficacy of Non-Invasive Neuromodulation on Pain in Migraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive Transcranial Magnetic Stimulation (rTMS)
Devicerobot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
sham repetitive Magnetic Transcranial Stimulation (rTMS)
Devicesham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: rTMS stimulationExperimental treatment 1 intervention
Group B: sham rTMS stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-treatmentSecondary outcomes
1
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-treatment2
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-treatment3
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
Time frame
at week 12Other outcomes
1
Bang blinding index
The patient will be asked what he thinks he received after the treatment, rTMS neuromodulation or sham neuromodulation
Time frame
week 0, week 2, week 4, week 6, week 8, week 122
Variation of blood cytokine levels
Following cytokines levels will be assessed : IL-6, IL-10, IL-17, IL-18, IL-1α, IL-1β, IL-21, IL-22, IL-23, IL-33, IL-35, CCL-20, IL-36β, IL-37, IL-38, IL-1Ra, TNFa, TGFβ, IL-2, INF-γ
Time frame
Before (Week 0) and after treatment (Weeks 8 and 12)3
Variation of headaches days number per month
Time frame
Every each 4-week period post-treatment, compared to 4 weeks before treatment initiation4
Migraine Hypersensitivity Assessment Questionnaire (MHQ-8 scale, ex-MIGAL) score
This scale assesses the frequency and intensity of disturbances related to noise, light, skin stimulation, and odors during migraines
Time frame
Pre-treatment period (inclusion visit at W0 - 4) and at week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: