Bilateral DLPC tDCS in Drug-resistant Migraine

Sponsor

Clínica de Intervención en Neurociencias (Other)

Overall Status

Completed

CT.gov ID

NCT06079801

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Device: Transcranial direct current stimulation (tDCS) Drug: anti-CGRP-mAbs	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy in Drug-resistant Migraine

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Apr 30, 2023

Actual Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real tDCS 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	Device: Transcranial direct current stimulation (tDCS) TDCS was delivered by a DC-Stimulator (Newronika, Italy) over both DLPC. The electrodes (35 cm2) were soaked in 0.9% NaCl. The anode was positioned on the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex.
Placebo Comparator: Sham tDCS 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	Device: Transcranial direct current stimulation (tDCS) TDCS was delivered by a DC-Stimulator (Newronika, Italy) over both DLPC. The electrodes (35 cm2) were soaked in 0.9% NaCl. The anode was positioned on the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex.
Active Comparator: anti-CGRP Patients will undergo anti-CGRP treatment	Drug: anti-CGRP-mAbs CGRP-mAbs have been the first target-driven treatment to be approved for migraine prevention. Their efficacy and safety have been demonstrated in randomized controlled trials (RCT) as well as, in real-world evidence (RWE) studies

Arm

Intervention/Treatment

Experimental: Real tDCS

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

Device: Transcranial direct current stimulation (tDCS)

TDCS was delivered by a DC-Stimulator (Newronika, Italy) over both DLPC. The electrodes (35 cm2) were soaked in 0.9% NaCl. The anode was positioned on the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex.

Placebo Comparator: Sham tDCS

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

Device: Transcranial direct current stimulation (tDCS)

Active Comparator: anti-CGRP

Patients will undergo anti-CGRP treatment

Drug: anti-CGRP-mAbs

CGRP-mAbs have been the first target-driven treatment to be approved for migraine prevention. Their efficacy and safety have been demonstrated in randomized controlled trials (RCT) as well as, in real-world evidence (RWE) studies

Outcome Measures

Primary Outcome Measures

Migraine attacks monthly frequency [baseline, 2 weeks after the end of the treatment, 6 months]
Patients will report migraine monthly frequency for the 3 different time-points
Headache Impact Test (HIT-6) score [baseline, 2 weeks after the end of the treatment, 6 months]
HIT-6 is a tool used to measure the impact headaches have on patient's ability to function on the job, at school, at home and in social situations.
Pain killer drugs monthly taken [baseline, 2 weeks after the end of the treatment, 6 months]
Patients will report pain-killer drugs taken during a month for the 3 different time-points

Secondary Outcome Measures

The Pittsburgh Sleep Quality Index (PSQI) [baseline, 2 weeks after the end of the treatment, 6 months]
PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Brief Symptom Inventory (BSI) [baseline, 2 weeks after the end of the treatment, 6 months]
The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.