Migraine DisordersNCT05706077
Effects of tDCS and Physical Therapy in Chronic Migraine
A study testing active tDCS and real Physical Therapy in people with Migraine Disorders, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- active tDCS and real Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Mar 2023to 28 Feb 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women;
- 18-50 years old;
- with Chronic Migraine according to ICHD-3 beta;
- literate;
- stable on routine medications specific for MC for at least 2 months, who were not undergoing other types of non-pharmacological interventions for MC, not lactating or pregnant, without neurological diseases or serious neuropsychiatric diseases, without other types of associated headaches, without signs and/or symptoms of spinal radiculopathy, without metal implants located in the head and/or cochlear implants.
Who cannot join
- who perhaps become pregnant during the execution of the clinical trial
- present some disease that disables their continuity in the treatment
- start another type of treatment
- show changes in physical activity and/or eating routine during the research
- has severe depression (BDI > 35).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of tDCS and Physical Therapy on Pain in Women With Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded
The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model.
Read the detailed description
A factorial, randomized clinical trial will be conducted to evaluate pain control, the number of migraine attacks, quality of life, emotional dysfunctions, and attentional processing of migraine patients.
Clinical outcomes will be evaluated through (I) a Visual Analog Scale (VAS); (II) pressure pain threshold; (III) a Headache Impact Test (HIT-6); (IV) a Migraine Disability Assessment (MIDAS); (V) Short-Form Health Survey Questionnaire de 36 items (SF-36); (VI) Patients' Global Impression of Change Scale (PGICS); (VII) Beck Depression Inventory (BDI); (VIII) State-Trait Anxiety Inventory (S-TAI); (IX) Perceived Stress Scale (PSS); and (X) Facial Expression Database.
- Conditions
- Migraine Disorders
- Being tested
- active tDCS, sham tDCS, real Physical Therapy, placebo Physical Therapy
- Keywords
- physical therapy, transcranial direct current stimulation, facial recognition
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
The electrode will measure 5x5 cm and a current of 2mA will be applied for 20 minutes. The current density will be 0.08mA/cm². tDCS will be applied three times a week for 20 minutes over four weeks.
sham tDCSDevice
The electrode will measure 5x5 cm. The sham-type current will show a rising ramp where the initial 30 seconds will be real current with the same parameter as the active group. After this time, the current will be automatically stopped by the device. tDCS will be applied three times a week for 20 minutes over four weeks.
real Physical TherapyOther
Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.
placebo Physical TherapyOther
The placebo Physical Therapy will be applied for 30 minutes, three times a week over four weeks. The initial 20 minutes will be used for the application of simulated ultrasound bilaterally in the middle portion of the upper trapezius muscle. In the final 10 minutes, the researcher will place the palms of the hand under the occipital region without applying any force or movement with the participant in the supine position.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS + real Physical Therapy | Experimental | Active Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites.
To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region. Receives: Device: active tDCS; Other: real Physical Therapy |
| active tDCS + placebo Physical Therapy | Placebo comparator | Active Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites.
To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region. Receives: Device: active tDCS; Other: placebo Physical Therapy |
| sham tDCS + real Physical Therapy | Sham comparator | Sham Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region. Receives: Device: sham tDCS; Other: real Physical Therapy |
| sham tDCS + placebo Physical Therapy | Other | Sham Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region. Receives: Device: sham tDCS; Other: placebo Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale
This scale will be used to measure the patients' pain intensity. The scale consists of a 100 mm line within the limits of no pain and worst possible pain. The patient is instructed to trace the intensity of his pain within the limits of the line. Changes of 1.1 to 1.2 cm indicate minimal clinical improvement.
Measured: baseline, one month, two month
pressure pain threshold
We analyzed the following points with the pressure algometer: anterior and posterior fibers of the temporal muscle, frontal region, insertion of the sternocleidomastoid muscle, insertion and middle fibers of the upper trapezius muscle, thenar region of the right upper limb.
Measured: baseline, one month, two month
Secondary outcomes (8)
Headache Impact Test
This test assesses the impact of headache on quality of life. A total score less than 50 means no severity; between 50 and 55, some severity; between 56 and 59, substantial severity; greater than 60, severe impact.
Measured: baseline, one month, two month
Migraine Disability Assessment
This questionnaire assesses the inability to perform activities of daily living of people with migraine.The MIDAS score is divided into grades: Grade I - little or no disability (scores 0-5), grade II - mild disability (scores 6-10), grade III - moderate disability (scores 11-20), and grade IV - severe disability (score equal to or greater than 21).
Measured: baseline, one month, two month
Short-Form Health Survey Questionnaire
This questionnaire assesses health-related quality of life. This test consists of 36 items. Higher scores indicate greater functionality.
Measured: baseline, one month, two month
Patients' Global Impression of Change Scale
This scale rates the improvement associated with the intervention on a 7-item scale ranging from "1=no change" to "7=much better".
Measured: baseline, one month, two month
Beck Depression Inventory
This questionnaire assesses the participants' level of depression. Scores between 0-11 mean minimal depression; between 12-19: mild depression; between 20-35: moderate depression and between 36-63: severe depression.
Measured: baseline, one month, two month
State-Trait Anxiety Inventory
This instrument assesses the participants' anxiety. It consists of 40 statements that consider trait anxiety and state anxiety. Answers are given on a four-point Likert-type scale (1 - not to 4 - very much), and the score can vary between 20-80. Anxiety level classification can be low (20-33 points), medium (33-49 points), and high (49-80 points).
Measured: baseline, one month, two month
Perceived Stress Scale
It is an instrument composed of 14 questions with response options ranging from zero to four (0=never; 1=almost never; 2=sometimes; 3=almost always, and 4=always). Questions with a positive connotation (4, 5, 6, 7, 9, 10, and 13) have their scores inverted: 0=4, 1=3, 2=2, 3=1, and 4=0. The other questions have negative valence and are added directly. The score is the sum of the scores for each question and can range from 0 to 56.
Measured: baseline, one month, two month
Facial Expression Database
This is an instrument that evaluates the recognition of facial expressions. The bank of faces from Lacop - Facial Expression Database will be used with expressions of joy, fear, anger, sadness, disgust, and surprise from two male and two female models. The manipulation of the intensity of the expressions will be carried out through the Morpheus 4.0 Software to generate faces with different emotional intensities with incremental advances of 25% from the neutral face until reaching 100% of expression intensity.
Measured: baseline, one month, two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start25 Mar 2023
- Primary completion25 Apr 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Factorial
- Model description
- Participants will be randomized into four intervention groups: transcranial Direct Current Stimulation + Physical Therapy Group (tDCS active + PT active), tDCS group (tDCS active + PT placebo), PT group (tDCS sham + PT active), control group (tDCS sham + PT placebo ).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Emanuela Lyra de Brito Aranha, Federal University of Paraíba
- Investigators
- Renata Aranha, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706077
- Sponsor's protocol ID
- 65756722.6.0000.5188
- Status last verified
- Sep 2025
- First submitted
- 29 Dec 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS and Physical Therapy on Pain in Women With Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded
- ClinicalTrials.gov ID
- NCT05706077
- Acronym / sponsor ID
- 65756722.6.0000.5188
- Conditions
- Migraine Disorders
- Keywords
- physical therapy, transcranial direct current stimulation, facial recognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 31 Jan 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 aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model.
Detailed description
A factorial, randomized clinical trial will be conducted to evaluate pain control, the number of migraine attacks, quality of life, emotional dysfunctions, and attentional processing of migraine patients.
Clinical outcomes will be evaluated through (I) a Visual Analog Scale (VAS); (II) pressure pain threshold; (III) a Headache Impact Test (HIT-6); (IV) a Migraine Disability Assessment (MIDAS); (V) Short-Form Health Survey Questionnaire de 36 items (SF-36); (VI) Patients' Global Impression of Change Scale (PGICS); (VII) Beck Depression Inventory (BDI); (VIII) State-Trait Anxiety Inventory (S-TAI); (IX) Perceived Stress Scale (PSS); and (X) Facial Expression Database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized into four intervention groups: transcranial Direct Current Stimulation + Physical Therapy Group (tDCS active + PT active), tDCS group (tDCS active + PT placebo), PT group (tDCS sham + PT active), control group (tDCS sham + PT placebo ).
| Arm | Type | Receives |
|---|---|---|
| active tDCS + real Physical Therapy | Experimental | Device: active tDCS, Other: real Physical TherapyActive Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region. |
| active tDCS + placebo Physical Therapy | Placebo comparator | Device: active tDCS, Other: placebo Physical TherapyActive Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region. |
| sham tDCS + real Physical Therapy | Sham comparator | Device: sham tDCS, Other: real Physical TherapySham Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region. |
| sham tDCS + placebo Physical Therapy | Other | Device: sham tDCS, Other: placebo Physical TherapySham Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women;
- 18-50 years old;
- with Chronic Migraine according to ICHD-3 beta;
- literate;
- stable on routine medications specific for MC for at least 2 months, who were not undergoing other types of non-pharmacological interventions for MC, not lactating or pregnant, without neurological diseases or serious neuropsychiatric diseases, without other types of associated headaches, without signs and/or symptoms of spinal radiculopathy, without metal implants located in the head and/or cochlear implants.
Key exclusion criteria (5 listed)
- who perhaps become pregnant during the execution of the clinical trial
- present some disease that disables their continuity in the treatment
- start another type of treatment
- show changes in physical activity and/or eating routine during the research
- has severe depression (BDI > 35).
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 |
|---|---|---|
| active tDCSThe electrode will measure 5x5 cm and a current of 2mA will be applied for 20 minutes. The current density will be 0.08mA/cm². tDCS will be applied three times a week for 20 minutes over four weeks. | Device | active tDCS + placebo Physical Therapy, active tDCS + real Physical Therapy |
| sham tDCSThe electrode will measure 5x5 cm. The sham-type current will show a rising ramp where the initial 30 seconds will be real current with the same parameter as the active group. After this time, the current will be automatically stopped by the device. tDCS will be applied three times a week for 20 minutes over four weeks. | Device | sham tDCS + placebo Physical Therapy, sham tDCS + real Physical Therapy |
| real Physical TherapyManual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks. | Other | active tDCS + real Physical Therapy, sham tDCS + real Physical Therapy |
| placebo Physical TherapyThe placebo Physical Therapy will be applied for 30 minutes, three times a week over four weeks. The initial 20 minutes will be used for the application of simulated ultrasound bilaterally in the middle portion of the upper trapezius muscle. In the final 10 minutes, the researcher will place the palms of the hand under the occipital region without applying any force or movement with the participant in the supine position. | Other | active tDCS + placebo Physical Therapy, sham tDCS + placebo Physical Therapy |
Primary outcome
Visual Analogic Scale
Time frame: baseline, one month, two month
This scale will be used to measure the patients' pain intensity. The scale consists of a 100 mm line within the limits of no pain and worst possible pain. The patient is instructed to trace the intensity of his pain within the limits of the line. Changes of 1.1 to 1.2 cm indicate minimal clinical improvement.
pressure pain threshold
Time frame: baseline, one month, two month
We analyzed the following points with the pressure algometer: anterior and posterior fibers of the temporal muscle, frontal region, insertion of the sternocleidomastoid muscle, insertion and middle fibers of the upper trapezius muscle, thenar region of the right upper limb.
8 secondary outcomes
Headache Impact Test
Time frame: baseline, one month, two month
Migraine Disability Assessment
Time frame: baseline, one month, two month
Short-Form Health Survey Questionnaire
Time frame: baseline, one month, two month
Patients' Global Impression of Change Scale
Time frame: baseline, one month, two month
Beck Depression Inventory
Time frame: baseline, one month, two month
State-Trait Anxiety Inventory
Time frame: baseline, one month, two month
Perceived Stress Scale
Time frame: baseline, one month, two month
Facial Expression Database
Time frame: baseline, one month, two month
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 3 Oct 2025.
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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.
Renata Aranha principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS and real Physical Therapy in people with Migraine Disorders, run by Federal University of Paraíba at 1 site in Brazil.
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 5 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 3 Oct 2025. 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 Brazil. 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?
Visual Analogic Scale (time frame: baseline, one month, two month). The study lists 2 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 3 Oct 2025.