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Transcranial Direct Current Stimulation Plus Monoclonal Antibodies Acting on the CGRP Pathway for Migraine

NCT ID: NCT05161871

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2023-04-16

Brief Summary

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Electrophysiological changes that occur in the brains of migraine patients, lead to the activation of nociceptive centers, including a peripheral neural structure, the trigeminal ganglion (TG), which releases pain-inducing peptides and mostly calcitonin gene-related peptide (CGRP). Monoclonal antibodies acting on the CGRP pathway (CGRP-MAbs) are the first drugs specifically designed for migraine, they inhibit CGRP release from the TG without entering the brain. Not all patients experience benefit from CGRP-MAbs treatment. For this reason, associating these drugs with a non-pharmacological treatment that acts centrally, such as transcranial direct current stimulation, could be effective.

The aim of the study is investigating how the migraine preventive treatment with CGRP-MAbs in association with tDCS, is effective to reduce headache days, days of disabling headache, intensity of pain and consumption of acute treatments. Migraine-related disability, quality of life, sleep disturbance and psychological aspects will also be evaluated. Patients will be randomized into two groups, one will receive active tDCS and one sham tDCS. Both patients and investigators will be blind to the treatment administered (double-blind).

Furthermore, will be evalutated the cortical mechanisms involved in migraine by directly modulating brain physiology via repetitive tDCS in patients with migraine on treatment with CGRP-MAbs. To fulfill this aim, we will assess the EEG correlates of the actual effects of the stimulation in a sham-controlled study, providing the EEG indexes linked to the altered and potentially restored cortical dynamics in migraine.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cathodal transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Cathodal transcranial direct current stimulation

Intervention Type DEVICE

The cathodal transcranial direct current stimulation protocol will consist in five daily sessions, each lasting 20 min. The montage will provide a bilateral stimulation on occipital areas, with the reference anodal electrodes positioned on the M1 areas. The stimulation will be applied via 4 conductive-rubber square electrodes (5x5 cm) placed in sponges saturated with high conductivity gel and connected to a battery-operated stimulator system. Direct current with maximal intensity of 1.5 mA with be provided for 20 minutes.

Sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Sham cathodal transcranial direct current stimulation

Intervention Type DEVICE

Sham stimulation will be performed by the same protocol as active stimulation; however, the device will be switched off 30 seconds after the beginning of stimulation. This way, the patient will experience the same sensations as with active stimulation without receiving actual stimulation.

Interventions

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Cathodal transcranial direct current stimulation

The cathodal transcranial direct current stimulation protocol will consist in five daily sessions, each lasting 20 min. The montage will provide a bilateral stimulation on occipital areas, with the reference anodal electrodes positioned on the M1 areas. The stimulation will be applied via 4 conductive-rubber square electrodes (5x5 cm) placed in sponges saturated with high conductivity gel and connected to a battery-operated stimulator system. Direct current with maximal intensity of 1.5 mA with be provided for 20 minutes.

Intervention Type DEVICE

Sham cathodal transcranial direct current stimulation

Sham stimulation will be performed by the same protocol as active stimulation; however, the device will be switched off 30 seconds after the beginning of stimulation. This way, the patient will experience the same sensations as with active stimulation without receiving actual stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* male or female patients, aged between 40 and 70 years, referring to the Headache Center of the University of L'Aquila;
* a diagnosis of migraine with or without aura according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; https://ichd-3.org/);
* age at onset of migraine \<50 years;
* migraine must have been present for at least ≥ 12 months;
* treated with CGRP-MAbs (erenumab, fremanezumab or galcanezumab) according to clinical practice criteria for 90-180 days since the first subcutaneous administration (this time range was chosen to ensure a stable CGRP pathway inhibition);
* reporting \>4 monthly migraine days in the last 30 days of observation despite treatment with CGRP-MAbs;
* able to discriminate between migraine and tension-type headaches;
* written informed consent to participate in the study

Exclusion Criteria

* any migraine preventive medication other than CGRP-MAbs;
* secondary migraine;
* epilepsy or any other neurologic condition that may be worsened by transcranial electrical stimulation;
* metallic head implants, cardiac pacemaker or any other device that could malfunction or be displaced by electrical stimulation;
* pregnancy or lactation.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of L'Aquila

OTHER

Sponsor Role lead

Responsible Party

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Simona Sacco

Full Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of L'Aquila

L’Aquila, , Italy

Site Status

Countries

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Italy

References

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Ornello R, D'Atri A, De Icco R, De Santis F, Rosignoli C, Onofri A, Vaghi G, Cammarota F, Brancaccio C, Corrado M, Bighiani F, Grillo V, Sances G, Corigliano D, Salfi F, Tassorelli C, Ferrara M, Sacco S. Effectiveness of transcranial direct current stimulation and monoclonal antibodies acting on the CGRP as a combined treatment for migraine (TACTIC): Results of a randomized controlled trial. Cephalalgia. 2025 May;45(5):3331024251325567. doi: 10.1177/03331024251325567. Epub 2025 May 19.

Reference Type DERIVED
PMID: 40384614 (View on PubMed)

Ornello R, Rosignoli C, Caponnetto V, Pistoia F, Ferrara M, D'Atri A, Sacco S. Effectiveness of Transcranial Direct Current Stimulation and Monoclonal Antibodies Acting on the CGRP as a Combined Treatment for Migraine (TACTIC): Protocol for a Randomized, Double-Blind, Sham-Controlled Trial. Front Neurol. 2022 May 10;13:890364. doi: 10.3389/fneur.2022.890364. eCollection 2022.

Reference Type DERIVED
PMID: 35620782 (View on PubMed)

Other Identifiers

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201722 ID INT 193/21

Identifier Type: -

Identifier Source: org_study_id