Chronic Migraine as Defined by Criteria of International Headache Society (IHS)MedisNCT02120326
Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine
A study testing Transcranial direct current stimulation of the motor cortex and simulation of Transcranial direct current stimulation of the motor cortex in people with Chronic Migraine as Defined by Criteria of International Headache Society (IHS), run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
- What is being tested?
- Transcranial direct current stimulation of the motor cortex and simulation of Transcranial direct current stimulation of the motor cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2014to 23 Jun 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic migraine for more than 1 year
- Stable treatment since 1 month
- Frequency of migraine crisis is above 8 per month during last month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient agreeing not to try other migraine prophylactic treatment, throughout the study
- Patient's written consent
Who cannot join
- History of drug addiction, epilepsy, or severe head trauma with bone break
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- Presence of intracranial ferromagnetic material or an implanted stimulator
- Introduction of a new treatment for less than a month
- Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
- Person not understanding the study protocol
Trial locations and contacts
2 sites in 1 country.
France2 sites
Grenoble University Hospital
Grenoble, Isere, 38043
Hospital of Voiron
Voiron, Isere, 38500
About this study
Official title: Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.
Read the detailed description
Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).
Patients will have 5 evaluation examinations:
- The first, one before tDCS,
- The second, 1 month after the beginning of tDCS
- The third, immediately after the end of tDCS
- The fourth, 1 month after the end of tDCS
- And the last one, 3 months after the end of tDCS.
The physician responsible for conducting tDCS sessions will make the randomization via a website.
The physician in charge of the evaluation examinations will don't know the allocated treatment.
- Being tested
- Transcranial direct current stimulation of the motor cortex, simulation of Transcranial direct current stimulation of the motor cortex
- Keywords
- Chronic migraine, tDCS, Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation of the motor cortexDevice
The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
Stimulation parameters:
- 2 mA intensity
- Continuous stimulation for 20 min with rise times and fall times of 10 seconds each
simulation of Transcranial direct current stimulation of the motor cortexDevice
The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
Stimulation parameters:
- The intensity of the stimulation current is 2 mA
- The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation of the motor cortex |
| simulated tDCS | Placebo comparator | Not described Receives: Device: simulation of Transcranial direct current stimulation of the motor cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the evolution of seizure frequency between the two groups
Measured: Evolution of seizure frequency since base line to 3 months after the end of tDCS
Secondary outcomes (6)
Comparison of the evolution of seizure severity between the two groups
Headache Impact Test 6 (HIT-6) questionnaire
Measured: Evolution of seizure severity since base line to 3 months after the end of tDCS
Comparison of the evolution of crisis treatment use between the two groups
Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book.
Measured: Evolution of crisis treatment use since base line until 3 months after the end of tDCS
Comparison of the evolution of the disease impact between the two groups
Migraine Disability Assessment Scale (MIDAS) scale
Measured: Evolution of the disease impact since base line to 3 months after the end of tDCS
Comparison of the evolution of the patient satisfaction between the two groups
Clinical Global Impression (CGI) scale
Measured: Evolution of the patient satisfaction since base line to 3 months after the end of tDCS
Comparison of the evolution of the quality of life between the two groups
Short Form 12 (SF-12) quality of life questionnaire
Measured: Evolution of the quality of life since base line until 3 months after the end of tDCS
Comparison of the evolution of anxiety and depression levels between the two groups
Hospital Anxiety and Depression scale (HAD) questionnaire
Measured: Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study start5 May 2014
- Primary completion18 Dec 2019
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine as Defined by Criteria of International Headache Society (IHS)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HODAJ Hasan, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120326
- Sponsor's protocol ID
- DCIC13/48
- Acronym
- Medis
- Status last verified
- Nov 2020
- First submitted
- 15 Apr 2014
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25.
PubMed 35219923
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine
- ClinicalTrials.gov ID
- NCT02120326
- Acronym / sponsor ID
- Medis / DCIC13/48
- Keywords
- Chronic migraine, tDCS, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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 purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.
Detailed description
Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).
Patients will have 5 evaluation examinations:
- The first, one before tDCS,
- The second, 1 month after the beginning of tDCS
- The third, immediately after the end of tDCS
- The fourth, 1 month after the end of tDCS
- And the last one, 3 months after the end of tDCS.
The physician responsible for conducting tDCS sessions will make the randomization via a website.
The physician in charge of the evaluation examinations will don't know the allocated treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: Transcranial direct current stimulation of the motor cortex |
| simulated tDCS | Placebo comparator | Device: simulation of Transcranial direct current stimulation of the motor cortex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of chronic migraine for more than 1 year
- Stable treatment since 1 month
- Frequency of migraine crisis is above 8 per month during last month
- chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- Patient agreeing not to try other migraine prophylactic treatment, throughout the study
Key exclusion criteria (6 listed)
- History of drug addiction, epilepsy, or severe head trauma with bone break
- History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- Presence of intracranial ferromagnetic material or an implanted stimulator
- Introduction of a new treatment for less than a month
- Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
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 of the motor cortexThe area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: * 2 mA intensity * Continuous stimulation for 20 min with rise times and fall times of 10 seconds each | Device | active tDCS |
| simulation of Transcranial direct current stimulation of the motor cortexThe area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: * The intensity of the stimulation current is 2 mA * The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation. | Device | simulated tDCS |
Primary outcome
Comparison of the evolution of seizure frequency between the two groups
Time frame: Evolution of seizure frequency since base line to 3 months after the end of tDCS
6 secondary outcomes
Comparison of the evolution of seizure severity between the two groups
Time frame: Evolution of seizure severity since base line to 3 months after the end of tDCS
Comparison of the evolution of crisis treatment use between the two groups
Time frame: Evolution of crisis treatment use since base line until 3 months after the end of tDCS
Comparison of the evolution of the disease impact between the two groups
Time frame: Evolution of the disease impact since base line to 3 months after the end of tDCS
Comparison of the evolution of the patient satisfaction between the two groups
Time frame: Evolution of the patient satisfaction since base line to 3 months after the end of tDCS
Comparison of the evolution of the quality of life between the two groups
Time frame: Evolution of the quality of life since base line until 3 months after the end of tDCS
Comparison of the evolution of anxiety and depression levels between the two groups
Time frame: Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS
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 13 Aug 2025.
- Results publication: PubMed 35219923Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25.
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.
HODAJ Hasan, MD principal investigator
University Hospital, Grenoble
2 sites 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 of the motor cortex and simulation of Transcranial direct current stimulation of the motor cortex in people with Chronic Migraine as Defined by Criteria of International Headache Society (IHS), run by University Hospital, Grenoble at 2 sites in France.
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 6 inclusion and 6 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Comparison of the evolution of seizure frequency between the two groups (time frame: Evolution of seizure frequency since base line to 3 months after the end of tDCS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120326, which also lists 1 linked publication.
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 13 Aug 2025.