Effects of tDCS and Physical Therapy in Chronic Migraine

Federal University of Paraíba

Status: Completed

Conditions: Migraine Disorders

Treatments: Device: sham tDCS; Device: active tDCS; Other: real Physical Therapy; Other: placebo Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05706077

65756722.6.0000.5188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

active tDCS + real Physical Therapy

Experimental group

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.

Treatment:

Other: real Physical Therapy

Device: active tDCS

active tDCS + placebo Physical Therapy

Placebo Comparator group

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.

Treatment:

Other: placebo Physical Therapy

Device: active tDCS

sham tDCS + real Physical Therapy

Sham Comparator group

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.

Treatment:

Other: real Physical Therapy

Device: sham tDCS

sham tDCS + placebo Physical Therapy

Other group

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.

Treatment:

Other: placebo Physical Therapy

Device: sham tDCS