Clinical trial NCT06079801: Bilateral DLPC tDCS in Drug-resistant Migraine
Official title: Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy in Drug-resistant Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
drug-resistant
tDCS
DLPC
Neuromodulation
anti CGRP
Lead sponsor: Clínica de Intervención en Neurociencias
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Migraine attacks monthly frequency
timeFrame: baseline, 2 weeks after the end of the treatment, 6 months
measure: Headache Impact Test (HIT-6) score
timeFrame: baseline, 2 weeks after the end of the treatment, 6 months
measure: Pain killer drugs monthly taken
timeFrame: baseline, 2 weeks after the end of the treatment, 6 months
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 2 weeks after the end of the treatment, 6 months
measure: Brief Symptom Inventory (BSI)
timeFrame: baseline, 2 weeks after the end of the treatment, 6 months
Other outcomes:
Locations:
city: Talavera De La Reina
country: Spain
facility: Clinica de Intervencion en Neurociencias
state: Toledo
Study officials:
References: