Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

Study Overview
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Brief Summary
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This study aims to verify the efficacy / effectiveness of treatment with transcranial direct therapy (TDCS) in patients with Persistent Covid who present headaches, migraines and chronic pain, such as arthralgias and myalgias. Transcranial Direct Therapy is used in the field of Physiotherapy and Rehabilitation, with results that prove to be effective for the treatment of patients suffering from symptoms such as migraines, headaches, chronic pain, fibromyalgia or chronic neuropathic pain. As can be seen, in the case of patients with Persistent Covid we find several of these symptoms, so it is suggested that, if Transcranial Direct Current Therapy (TDCs) is giving such good results, relieving these symptoms, why can not give such good results and help so much in patients with Persistent Covid, If many of the symptoms are the same, even if the origin or cause is different.

Official Title
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Effectiveness of Transcranial Direct Current (tDCS) Treatment in Patients With Persistent Covid Who Present Headaches and Chronic Body Pain.

Conditions
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COVID-19, Myalgia, Long COVID, Long Covid19, SARS CoV 2 Infection, Persistent COVID-19, Migraine Disorders, Headaches Chronic, Cluster Headache, Arthralgia, Chronic Pain, Post-COVID-19 Syndrome, Post COVID-19 Condition

Intervention / Treatment
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* Device: Transcranial Direct Current Therapy (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Persistent Covid Men and women All ages from 16 years old Patients who passed the Covid in its acute phase in an asymptomatic, mild and severe way. Exclusion Criteria: Patients without confirmation with positive PCR in the acute phase of Covid-19 Patients with Persistent Covid who do not have at least one of these symptoms: migraines, headaches, chronic pain, neuropathic pain, arthralgia, myalgias Patients with pacemaker / defibrillator Patients with brain implants Patients with cranial fractures Pregnant

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Device: Transcranial Direct Current Therapy (tDCS)<br>* Transcranial direct therapy (tDCS) is a non-invasive neuromodulation therapy of the cerebral cortex, which consists of the application of electrical microcurrents, of approximately 2mA, through surface electrodes placed on the scalp. Transcranial therapy (tDCS) produces immediate effects on the ability of neurons to change their electrical potential. Each session lasts between 20 and 30 minutes, and approximately 10 consecutive sessions should be performed. It will be applied through two surface electrodes of 25 to 35 cm2 at 2 mA. The equipment has a European health certificate (CE), so it is an approved equipment that complies with all the safety measures for the application of the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS | MEASURED WITH 2 SPECIFIC PAIN SCALES (EVA-Visual Analog SCALE AND MCGILL PAIN QUESTIONNAIRE). EVA SCALE (0 no pain-10 maximun pain). MCGILL QUESTIONNAIRE (0 no pain-66 maximun pain) | PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS | 
| CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS | MEASURED WITH 2 SPECIFIC SCALES (MIDAS-Migraine dissability Assessment SCALE AND HIT-6 QUESTIONNAIRE-headache impact test). MIDAS SCALE (0 nil disability - >21 severe disability). HIT-6 QUESTIONNAIRE (0 no impact - >60 very severe impact). | PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS | MEASURED WITH 1 SPECIFIC SCALE (SF-12 QUESTIONNAIRE). (0 worst quality of life - 100 best quality of life) | PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS | 
| CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS | MEASURED WITH 1 SPECIFIC SCALE (EVEA-mood rating SCALE). (0 nothing - 10 a lot) | PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation, tDCS, Covid Persistente