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NCT Number: NCT06079801

Bilateral DLPC tDCS in Drug-resistant Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica de Intervencion en Neurociencias

Talavera de la Reina, Toledo, 45600, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

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-mAbs

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

Primary outcomes

  1. Migraine attacks monthly frequency

    Time frame: baseline, 2 weeks after the end of the treatment, 6 months

    Patients will report migraine monthly frequency for the 3 different time-points

  2. Headache Impact Test (HIT-6) score

    Time frame: 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.

  3. Pain killer drugs monthly taken

    Time frame: 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 outcomes

  1. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  2. Brief Symptom Inventory (BSI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clínica de Intervención en Neurociencias

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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