Bilateral DLPC tDCS in Drug-resistant Migraine

October 15, 2023 updated by: Michele Dileone, Clínica de Intervención en Neurociencias

Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Clinica de Intervencion en Neurociencias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
Placebo Comparator: 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
Device: 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.
Active Comparator: anti-CGRP
Patients will undergo anti-CGRP treatment
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2 weeks after the end of the treatment, 6 months
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.
baseline, 2 weeks after the end of the treatment, 6 months
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
baseline, 2 weeks after the end of the treatment, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 2 weeks after the end of the treatment, 6 months
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.
baseline, 2 weeks after the end of the treatment, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica de Intervención en Neurociencias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClinicaIN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will publish results of the study and we will provide more information for reviewers if required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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