MigraineNCT06079801
Bilateral DLPC tDCS in Drug-resistant Migraine
A study testing Transcranial direct current stimulation (tDCS) and anti-CGRP-mAbs in people with Migraine, run by Clínica de Intervención en Neurociencias at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine
- What is being tested?
- Transcranial direct current stimulation (tDCS) and anti-CGRP-mAbs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica de Intervencion en Neurociencias
Talavera de la Reina, Toledo, 45600
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Migraine
- Being tested
- Transcranial direct current stimulation (tDCS), anti-CGRP-mAbs
- Keywords
- migraine, drug-resistant, tDCS, DLPC, Neuromodulation, anti CGRP
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-mAbsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | 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 Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Placebo comparator | 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 Receives: Device: Transcranial direct current stimulation (tDCS) |
| anti-CGRP | Active comparator | Patients will undergo anti-CGRP treatment Receives: Drug: anti-CGRP-mAbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attacks monthly frequency
Patients will report migraine monthly frequency for the 3 different time-points
Measured: 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.
Measured: 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
Measured: baseline, 2 weeks after the end of the treatment, 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline, 2 weeks after the end of the treatment, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Oct 2021
- Primary completion30 Apr 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Intervención en Neurociencias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Dileone, Clínica de Intervención en Neurociencias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079801
- Sponsor's protocol ID
- ClinicaIN01
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish results of the study and we will provide more information for reviewers if required
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy in Drug-resistant Migraine
- ClinicalTrials.gov ID
- NCT06079801
- Acronym / sponsor ID
- ClinicaIN01
- Conditions
- Migraine
- Keywords
- migraine, drug-resistant, tDCS, DLPC, Neuromodulation, anti CGRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Clínica de Intervención en NeurocienciasUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: Transcranial direct current stimulation (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 |
| Sham tDCS | Placebo comparator | 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 |
| anti-CGRP | Active comparator | Drug: anti-CGRP-mAbsPatients will undergo anti-CGRP treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Real tDCS, Sham tDCS |
| anti-CGRP-mAbsCGRP-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 | Drug | anti-CGRP |
Primary outcome
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
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.
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
2 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No. We will publish results of the study and we will provide more information for reviewers if required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and anti-CGRP-mAbs in people with Migraine, run by Clínica de Intervención en Neurociencias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine attacks monthly frequency (time frame: baseline, 2 weeks after the end of the treatment, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.