Back to resultsEffects of tDCS and Physical Therapy in Chronic Migraine
Primary Purpose
Migraine Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
active tDCS
sham tDCS
real Physical Therapy
placebo Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring physical therapy, transcranial direct current stimulation, facial recognition
Eligibility Criteria
Inclusion Criteria: Women; 18-50 years old; with Chronic Migraine according to ICHD-3 beta; literate; without excessive use of headache medications, not undergoing other types of non-pharmacological interventions for CM, not lactating or pregnant, not having associated neurological or neuropsychiatric diseases, without other types of headache, without rheumatic diseases, without signs and/or symptoms of spinal radiculopathy, without metallic implants located in the head and/or cochlear implants. Exclusion Criteria: started a new pharmacological treatment for migraine less than 3 months before participating in the study or modifying the administration of continuous medication during the research 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).
Sites / Locations
- Federal University of ParaibaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Sham Comparator
Other
Arm Label
active tDCS + real Physical Therapy
active tDCS + placebo Physical Therapy
sham tDCS + real Physical Therapy
sham tDCS + placebo Physical Therapy
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
diary headache
This diary will be self-reported daily to assess headache frequency.
Secondary Outcome Measures
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.
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).
Short-Form Health Survey Questionnaire
This questionnaire assesses health-related quality of life. This test consists of 36 items. Higher scores indicate greater functionality.
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".
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.
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).
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.
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.
Full Information
NCT ID
NCT05706077
First Posted
December 29, 2022
Last Updated
January 20, 2023
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT05706077
Brief Title
Effects of tDCS and Physical Therapy in Chronic Migraine
Official Title
Effects of tDCS and Physical Therapy on Pain in Women With Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity and frequency of pain 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) a headache diary; (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
physical therapy, transcranial direct current stimulation, facial recognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS + real Physical Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
active tDCS + placebo Physical Therapy
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
sham tDCS + real Physical Therapy
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
sham tDCS + placebo Physical Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
real Physical Therapy
Intervention Description
Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.
Intervention Type
Other
Intervention Name(s)
placebo Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogic Scale
Description
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.
Time Frame
baseline; after 1 month; after 3 month;
Title
diary headache
Description
This diary will be self-reported daily to assess headache frequency.
Time Frame
3 followed months (one month before tDCS, during tDCS, and one month after tDCS)
Secondary Outcome Measure Information:
Title
Headache Impact Test
Description
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.
Time Frame
baseline; after 1 month; after 3 month;
Title
Migraine Disability Assessment
Description
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).
Time Frame
baseline; after 1 month; after 3 month;
Title
Short-Form Health Survey Questionnaire
Description
This questionnaire assesses health-related quality of life. This test consists of 36 items. Higher scores indicate greater functionality.
Time Frame
baseline; after 1 month; after 3 month;
Title
Patients' Global Impression of Change Scale
Description
This scale rates the improvement associated with the intervention on a 7-item scale ranging from "1=no change" to "7=much better".
Time Frame
baseline; after 1 month; after 3 month;
Title
Beck Depression Inventory
Description
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.
Time Frame
baseline; after 1 month; after 3 month;
Title
State-Trait Anxiety Inventory
Description
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).
Time Frame
baseline; after 1 month; after 3 month;
Title
Perceived Stress Scale
Description
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.
Time Frame
baseline; after 1 month; after 3 month;
Title
Facial Expression Database
Description
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.
Time Frame
baseline; after 1 month; after 3 month;
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women;
18-50 years old;
with Chronic Migraine according to ICHD-3 beta;
literate;
without excessive use of headache medications, not undergoing other types of non-pharmacological interventions for CM, not lactating or pregnant, not having associated neurological or neuropsychiatric diseases, without other types of headache, without rheumatic diseases, without signs and/or symptoms of spinal radiculopathy, without metallic implants located in the head and/or cochlear implants.
Exclusion Criteria:
started a new pharmacological treatment for migraine less than 3 months before participating in the study or modifying the administration of continuous medication during the research
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Aranha, master
Phone
(83)988128339
Email
renataemanuelalb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Aranha
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Paraiba
City
João Pessoa
State/Province
Paraiba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Aranha
Email
renataemanuelalb@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of tDCS and Physical Therapy in Chronic Migraine
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