NCT05161871

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

Effectiveness of tDCS and Monoclonals Antibodies Anti-CGRP as a Combined Treatment for Migraine: a Randomized, Double-blind, Sham-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2022-05-16
• Primary completion: 2023-01-16
• Completion: 2023-04-16
• First posted: 2021-12-17
• Last updated: 2024-12-05

Locations

1 site across 1 country: Italy