An interventional study of Transcranial direct current stimulation (tDCS) and anti-CGRP-mAbs in Migraine, sponsored by Clínica de Intervención en Neurociencias. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Clínica de Intervención en Neurociencias · Not applicable, Interventional, and Treatment
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:
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Clínica de Intervención en Neurociencias as lead sponsor.
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Exclusion Criteria:
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)
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)
Patients will undergo anti-CGRP treatment
Drug: anti-CGRP-mAbs
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.
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
Migraine attacks monthly frequency
Patients will report migraine monthly frequency for the 3 different time-points
Time frame: baseline, 2 weeks after the end of the treatment, 6 months
Headache Impact Test (HIT-6) score
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.
Time frame: baseline, 2 weeks after the end of the treatment, 6 months
Pain killer drugs monthly taken
Patients will report pain-killer drugs taken during a month for the 3 different time-points
Time frame: baseline, 2 weeks after the end of the treatment, 6 months
The Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: baseline, 2 weeks after the end of the treatment, 6 months
Brief Symptom Inventory (BSI)
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.
Time frame: baseline, 2 weeks after the end of the treatment, 6 months
Plan to share: No — We will publish results of the study and we will provide more information for reviewers if required
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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