Effects of tDCS and Physical Therapy in Chronic Migraine

NCT05706077 | Completed DMC

• 1 other identifier: 65756722.6.0000.5188
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Disorders

Keywords

physical therapy; transcranial direct current stimulation; facial recognition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, one month, two month

Secondary Outcomes (8)

• Headache Impact Test

  baseline, one month, two month

• Migraine Disability Assessment

  baseline, one month, two month

• Short-Form Health Survey Questionnaire

  baseline, one month, two month

• Patients' Global Impression of Change Scale

  baseline, one month, two month

• Beck Depression Inventory

  baseline, one month, two month

Study Arms (4)

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.

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.

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.

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.

Device: sham tDCS; Other: placebo Physical Therapy

Interventions

active tDCS DEVICE

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.

active tDCS + placebo Physical Therapy; active tDCS + real Physical Therapy

sham tDCS DEVICE

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.

sham tDCS + placebo Physical Therapy; sham tDCS + real Physical Therapy

real Physical Therapy OTHER

Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.

active tDCS + real Physical Therapy; sham tDCS + real Physical Therapy

placebo Physical Therapy OTHER

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.

active tDCS + placebo Physical Therapy; sham tDCS + placebo Physical Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women;
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Renata Aranha

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, master's degree in cognitive and behavioral neuroscience

Model Details: 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 ).

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 31, 2023
• Study Start: March 25, 2023
• Primary Completion: April 25, 2024
• Study Completion: February 28, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

BR (1)