Bilateral DLPC tDCS in Drug-resistant Migraine

NCT ID: NCT06079801

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-08-31

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.

Conditions

Migraine

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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.

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

Group Type: PLACEBO_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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.

anti-CGRP

Patients will undergo anti-CGRP treatment

Group Type: ACTIVE_COMPARATOR

anti-CGRP-mAbs

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica de Intervención en Neurociencias

OTHER

Sponsor Role: lead

Responsible Party

Michele Dileone

MD, PhD, Principal Investigator, Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica de Intervencion en Neurociencias

Talavera de la Reina, Toledo, Spain

Countries

Spain

Other Identifiers

ClinicaIN01

Identifier Type: -

Identifier Source: org_study_id