Bilateral DLPC tDCS in Drug-resistant Migraine

Clínica de Intervención en Neurociencias

Status: Completed

Conditions: Migraine

Treatments: Drug: anti-CGRP-mAbs; Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06079801

ClinicaIN01

Details and patient eligibility

About

The goal of this clinical trial is to study and describe the effects of bilateral tDCS applied to dorso-lateral-prefrontal cortex (DLPC) in patients with drug-resistant migraine in terms of reduction in frequency of pain, impact of pain in daily life, quality of sleep and psychological measures. We finally planned to include high frequency and chronic migraine patients.

The main questions it aims to answer are:

• Will bilateral DLPC tDCS be feasible, well tolerated and safe in drug resistant migraine patients?
• Will bilateral DLPC tDCS be effective in reducing pain frequency, intensity and its impact in daily life activities?
• Will bilateral DLPC tDCS be effective in ameliorating sleep and psychological associated symptoms?
• Will bilateral DLPC tDCS be such effective in reducing pain frequency, intensity and its impact in daily life activities as anti-CGRP treatments?

Participants will undergo 2 tDCS sessions daily for 2 consecutive weeks. Patients will be blinded to treatment and will be divided in two groups (real vs placebo). A third group of patients, age-matched to the other two, will undergo anti-CGRP treatment. Patients will be asked to complete Patient-Reported Outcomes (PROMs) scales at baseline, one week after the end of the treatment and at 6 months after the end of the treatment.

Researchers (blinded to the treatment) will compare the group that underwent real tDCS treatment vs the one that underwent placebo tDCS vs the one that underwent anti-CGRP drugs to see if bilateral DLPC tDCS is effective in reducing migraine frequency, intensity and impact and if bilateral DLPC tDCS is such effective as anti-CGRP treatment.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of high-frequency and/or chronic migraines, according to the diagnostic criteria of the ICHD-III,
• failure to more than 3 preventive drugs
• stable pharmacological treatment (> 6 months without changes),
• absence of other neurological or medical pathological conditions,
• written informed consent.

Exclusion criteria

• seizures
• significant cognitive impairment that prevents following orders and understanding instructions (Mini-Mental State Examination < 23)
• pregnancy
• aphasia or limitations in communication,
• metallic cranial implants
• another neurological or psychiatric pathology
• diagnosis of another type of migraine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Real tDCS

Experimental group

Description:

Patients will undergo real tDCS applied to both DLPC. Two daily sessions of 20 minutes each were administered (40 minutes a day in total), with a 5-minutes break in between, 5 days a week (Monday to Friday) and with 20 tDCS sessions in total for participant

Treatment:

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

Placebo Comparator group

Description:

Patients will undergo sham tDCS applied to both DLPC. Two daily sessions of 20 minutes each were administered (40 minutes a day in total), with a 5-minutes break in between, 5 days a week (Monday to Friday) and with 20 tDCS sessions in total for participant

Treatment:

Device: Transcranial direct current stimulation (tDCS)

anti-CGRP

Active Comparator group

Description:

Patients will undergo anti-CGRP treatment

Treatment:

Drug: anti-CGRP-mAbs